Medical device 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 14, 2026, FDA's public records list Genchem, Inc. with 8 510(k) clearances. The most recent is a 510(k) clearance dated Jun 5, 2009: CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3.
| Jun 5, 2009 | CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3K090283 · JIX | 510(k) clearances |
| Dec 27, 2004 | GENCHEM ELECTROLYTE BUFFERK040977 · JGS | 510(k) clearances |
| Dec 27, 2004 | BUN REAGENTK040973 · CDS | 510(k) clearances |
| Dec 27, 2004 | GENCHEM CREATININE REAGENTK040976 · CGX | 510(k) clearances |
| Dec 27, 2004 | CALCIUM, AZO DYE REAGENTK040972 · CJY | 510(k) clearances |
| Dec 27, 2004 | GLUCOSE OXIDASE, GLUCOSEK040974 · CGA | 510(k) clearances |
| Dec 27, 2004 | GENCHEM CO2 ACID REAGENTK040975 · JFL | 510(k) clearances |
| Dec 22, 2004 | GENCHEM ISE ELECTROLYTE REFERENCEK040971 · JGS | 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
