Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Sterling Diagnostics with 41 510(k) clearances and 9 device recalls. The most recent is a device recall dated Jul 20, 2016: Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the q….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 20, 2016 | Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONClass III · Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previou | Device recalls |
| Jul 20, 2016 | Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLESClass III · Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previou | Device recalls |
| Jul 20, 2016 | Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - aClass III · Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previou | Device recalls |
| Jul 20, 2016 | Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes.Class III · Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previou | Device recalls |
| Jul 20, 2016 | Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABClass III · Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previou | Device recalls |
| Jul 20, 2016 | Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These arClass III · Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previou | Device recalls |
| Jul 20, 2016 | Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLClass III · Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previou | Device recalls |
| Jul 20, 2016 | Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLClass III · Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previou | Device recalls |
| Jan 21, 1993 | MICROPROTEIN REAGENT SETK921412 · CEK | 510(k) clearances |
| Nov 7, 1991 | TRIGLYCERIDES REAGENT SETK914609 · CDT | 510(k) clearances |
| Oct 31, 1991 | SODIUM REAGENT SETK914039 · CEI | 510(k) clearances |
| Oct 30, 1991 | PHOSPHOLIPID REAGENT SETK914040 · JNT | 510(k) clearances |
| Jul 29, 1986 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K862255 · CFJ | 510(k) clearances |
| Jul 7, 1986 | VANILMANDELIC ACID (VMA) REAGENT SETK861962 · CDF | 510(k) clearances |
| Jul 1, 1986 | UREA NITROGEN (GLDH) REAGENT SET (UV)K862210 · CDQ | 510(k) clearances |
| Jul 1, 1986 | ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SETK862256 · CJE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
