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 13, 2026, FDA's public records list Hycel, Inc. with 22 510(k) clearances. The most recent is a 510(k) clearance dated Oct 6, 1980: HYCEL TRIGYCERIDE II TEST.
| Date | Record | Source |
|---|---|---|
| Oct 6, 1980 | HYCEL TRIGYCERIDE II TESTK802422 · | 510(k) clearances |
| Feb 27, 1979 | HYCEL MK790335 · JJF | 510(k) clearances |
| Jan 26, 1979 | HYCEL LDH-INT TESTK782176 · CFH | 510(k) clearances |
| Jan 26, 1979 | KETOSTEROID TEST, HYCEL-17K782116 · CCY | 510(k) clearances |
| Jan 3, 1979 | HYCEL COUNTER 222K782101 · GKL | 510(k) clearances |
| Jan 3, 1979 | HYCEL COUNTER 211K782102 · GKL | 510(k) clearances |
| Jan 3, 1979 | HYCEL COUNTER 333K782100 · GKL | 510(k) clearances |
| Jul 27, 1978 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZERK780946 · JPJ | 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
