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 its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Clinical Assays with 27 510(k) clearances. The most recent is a 510(k) clearance dated Oct 4, 1983: VITAMIN B12 FOLATE CA-1515-125.
| Oct 4, 1983 | VITAMIN B12 FOLATE CA-1515-125K832711 · CDD | 510(k) clearances |
| Oct 4, 1983 | FOLATE RADIOASSAY KIT CA-1562-125K832712 · CGN | 510(k) clearances |
| Oct 4, 1983 | VITAMIN B12 RADIOASSAY KIT CA-1534K832710 · CDD | 510(k) clearances |
| Dec 28, 1982 | GAMMADAB LH RADIO-KIT #CA-1508K823476 · CEP | 510(k) clearances |
| Dec 22, 1982 | IN VITRO GAMMACOAT B-HCG RADIO. TESTK823313 · JHI | 510(k) clearances |
| Jun 24, 1982 | GAMMADAB [125] FSH RADIOIMMUNAY KITK821611 · CGJ | 510(k) clearances |
| Jun 22, 1982 | GAMMADAB[125]EGE RADIOIMMUNOASSAY ITK821092 · DGC | 510(k) clearances |
| Sep 24, 1981 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAYK812227 · CFP | 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
