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 Datachem, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jul 5, 1990: MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER.
| Date | Record | Source |
|---|---|---|
| Jul 5, 1990 | MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZERK900788 · CEM | 510(k) clearances |
| Mar 9, 1984 | APSARA ANALYZERK834534 · JJE | 510(k) clearances |
| Feb 9, 1983 | APSARA CLINICAL DIAG. & INFO. SYSK823386 · JJE | 510(k) clearances |
| Dec 9, 1981 | FLO TEM II (BLOOD/FLUID WARMERK813161 · LGZ | 510(k) clearances |
| May 21, 1981 | FLUID WARMERK803249 · LGZ | 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
