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 Wyntek Diagnostics with 12 510(k) clearances. The most recent is a 510(k) clearance dated Jan 18, 2000: OSOM ULTRA STREP A TEST, MODEL 147.
| Jan 18, 2000 | OSOM ULTRA STREP A TEST, MODEL 147K992658 · GTY | 510(k) clearances |
| Mar 9, 1999 | OSOM CARD PREGNANCY TEST, MODEL 103K990576 · LCX | 510(k) clearances |
| Mar 9, 1999 | OSOM CARD II HCG-URINE TEST, MODEL 102K990578 · JHI | 510(k) clearances |
| Dec 24, 1997 | OSOM HCG-URINE TEST MODEL 101K974159 · JHI | 510(k) clearances |
| Nov 4, 1997 | OSOM CARD HCG-URINE TESTK973879 · JHI | 510(k) clearances |
| Aug 26, 1997 | OSOM MONO TEST 143K972231 · KTN | 510(k) clearances |
| Feb 4, 1997 | PERFECTA PREGNANCY TESTK965184 · LCX | 510(k) clearances |
| Feb 4, 1997 | OSOM CLASSIC HCG-URINE TEST (115)K965227 · JHI | 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
