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., part of Roche. FDA records under its name, each linked to the record. See the Roche group view.
As of Nov 13, 2026, FDA's public records list Roche Analytical Instruments with 11 510(k) clearances. The most recent is a 510(k) clearance dated Jul 14, 1980: COBAS CK-NAC REAGENT.
| Jul 14, 1980 | COBAS CK-NAC REAGENTK801299 · CGS | 510(k) clearances |
| Jul 8, 1980 | COBAS REAGENT FOR A-AMYLASEK801295 · JFJ | 510(k) clearances |
| Jul 8, 1980 | COBAS REAGENT FOR TRIGLYCERIDES & COBASK801298 · CDT | 510(k) clearances |
| Jun 30, 1980 | COBAS REAGENT FOR GLUCOSE RAPIDK801297 · CFR | 510(k) clearances |
| Jun 30, 1980 | COBAS REAGENT FOR CHOLESTEROLK801296 · CHH | 510(k) clearances |
| Jun 26, 1980 | COBAS REAGENTS FOR URIC ACIDK801243 · CDO | 510(k) clearances |
| Jun 20, 1980 | COBAS REAGENT FOR AST (SGOT)K801118 · CIT | 510(k) clearances |
| Jun 20, 1980 | COBAS REAGENT FOR ALKALINE PHOSPHATASEK801242 · CJE | 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
