Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 Columbia Biosciences with 13 510(k) clearances. The most recent is a 510(k) clearance dated Sep 3, 1999: IS H. PYLORI IGG ELISA TEST SYSTEM.
| Sep 3, 1999 | IS H. PYLORI IGG ELISA TEST SYSTEMK990462 · LYR | 510(k) clearances |
| Sep 3, 1999 | MUMPS IGG ELISA TEST SYSTEMK991274 · LJY | 510(k) clearances |
| Feb 2, 1999 | IS ANTI-TPO IGG ELISA TEST SYSTEMK984228 · JZO | 510(k) clearances |
| Dec 16, 1998 | IS BORRELIA BURGDORFERI IGM TEST SYSTEMK983606 · LSR | 510(k) clearances |
| Dec 16, 1998 | IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMK983605 · LSR | 510(k) clearances |
| Dec 7, 1998 | ANTI-TG IGG ELISA TEST SYSTEMK983553 · JZO | 510(k) clearances |
| Nov 25, 1998 | EA-D IGM ELISA TEST SYSTEMK982350 · LSE | 510(k) clearances |
| Nov 25, 1998 | EBNA-1 IGM ELISA TEST SYSTEMK982348 · LSE | 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
