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 15, 2026, FDA's public records list Bio-Chem Laboratory Systems with 5 510(k) clearances. The most recent is a 510(k) clearance dated Apr 20, 1995: ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM.
| Apr 20, 1995 | ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEMK945271 · JJE | 510(k) clearances |
| Nov 10, 1993 | AUTOBEAD THYROID UPTAKEK930689 · KHO | 510(k) clearances |
| Sep 9, 1993 | AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KITK930006 · JLW | 510(k) clearances |
| Mar 18, 1993 | AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KITK926563 · CDX | 510(k) clearances |
| Sep 29, 1992 | ATAC 6000 CHEMISTRY ANALYZERK924084 · JJE | 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
