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 Gamma Enterprises with 23 510(k) clearances. The most recent is a 510(k) clearance dated May 15, 1979: GAMMA SMAC REAGENTS.
| May 15, 1979 | GAMMA SMAC REAGENTSK790578 · CIG | 510(k) clearances |
| May 3, 1978 | CREATINE PHOSPHOKINASE (CPK)K780504 · JHS | 510(k) clearances |
| May 3, 1978 | SERUM GLUTAMIC-PYRUVIC TRANSAMINASEK780507 · CKC | 510(k) clearances |
| May 3, 1978 | SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASEK780505 · CIT | 510(k) clearances |
| May 3, 1978 | CARBON DIOXIDE REAGENTSK780506 · KMS | 510(k) clearances |
| Nov 22, 1977 | LACTATE DEHYDROGENASEK771836 · CFJ | 510(k) clearances |
| Nov 22, 1977 | CHLORIDEK771832 · JFS | 510(k) clearances |
| Nov 22, 1977 | WETTING AGENTSK771843 · | 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
