Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 Pointe Scientific with 74 510(k) clearances and 3 device recalls. The most recent is a device recall dated May 19, 2015: Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1….
| Date | Record | Source |
|---|---|---|
| May 19, 2015 | Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual viaClass II · A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control | Device recalls |
| Mar 13, 2015 | Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 Class III · Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The | Device recalls |
| Dec 12, 2014 | Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: Class III · Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 v | Device recalls |
| Dec 4, 2007 | MICROPROTEIN REAGENT SETK070757 · JGP | 510(k) clearances |
| Jul 13, 2007 | POINTE 360K062118 · CFR | 510(k) clearances |
| Apr 30, 2007 | CARBON DIOXIDE LIQUID STABLE REAGENTK070251 · KHS | 510(k) clearances |
| Apr 13, 2007 | MULTI-ANALYTE CHEMISTRY CALIBRATORK070207 · JIX | 510(k) clearances |
| Apr 11, 2007 | AMMONIA/ALCOHOL CONTROL SETK070504 · JJY | 510(k) clearances |
| Mar 28, 2007 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORSK061377 · MSJ | 510(k) clearances |
| Oct 7, 2005 | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGHK051646 · JGS | 510(k) clearances |
| Jun 2, 2004 | TOTAL BILIRUBIN REAGENT SETK040391 · CIG | 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
