Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Diagnostic Specialties with 8 510(k) clearances. The most recent is a 510(k) clearance dated Sep 2, 1997: ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT.
| Sep 2, 1997 | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITK971458 · JIQ | 510(k) clearances |
| Aug 30, 1994 | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITK941001 · GIS | 510(k) clearances |
| Aug 19, 1993 | PROTEIN-BOUND GLUCOSE ASSAYN KITK930823 · LCP | 510(k) clearances |
| Jul 30, 1992 | ENZIP URINARY MICROALBUMIN TESTK922032 · JIR | 510(k) clearances |
| May 27, 1983 | PREGNA-CERT, SLIDE PREGNANCY TESTK831180 · JHJ | 510(k) clearances |
| Nov 10, 1982 | GENERIC PREGNANCY TESTK823109 · LCX | 510(k) clearances |
| Jan 22, 1982 | POTASSIUM REAGENT SETK813608 · CEJ | 510(k) clearances |
| Dec 31, 1981 | GLUCOSE ENZYME-COLOR REAGENT SETK813412 · CGA | 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
