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 13, 2026, FDA's public records list Diagnostic Systems with 14 510(k) clearances. The most recent is a 510(k) clearance dated Feb 4, 1991: OLYMPUS URINE PH.
| Date | Record | Source |
|---|---|---|
| Feb 4, 1991 | OLYMPUS URINE PHK905146 · JQY | 510(k) clearances |
| Aug 31, 1989 | EMDS CREATINE KINASE ITEM NIMBER 65411K893691 · CGS | 510(k) clearances |
| Aug 21, 1989 | EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405K893692 · CIT | 510(k) clearances |
| Jul 25, 1989 | HDL PRECIPITATING REAGENTK893966 · LBR | 510(k) clearances |
| Dec 29, 1988 | VISUAL BLOOD GLUCOSE TEST SYSTEMK884993 · CGA | 510(k) clearances |
| Jun 20, 1988 | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641K881116 · KLR | 510(k) clearances |
| Mar 15, 1988 | EASY-TEST LACTIC ACID (LA)K880787 · KHP | 510(k) clearances |
| Jul 11, 1986 | EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95K862403 · DKB | 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
