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 14, 2026, FDA's public records list Roche Diagnostics Systems with 296 510(k) clearances. The most recent is a 510(k) clearance dated May 3, 1999: MODIFICATION TO ABUSCREEN ONLINE BARBITURATES.
| May 3, 1999 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983698 · DIS | 510(k) clearances |
| Feb 11, 1999 | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983702 · JXM | 510(k) clearances |
| Feb 10, 1999 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983704 · JCM | 510(k) clearances |
| Dec 15, 1998 | ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983556 · DLJ | 510(k) clearances |
| Dec 15, 1998 | ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983555 · DLJ | 510(k) clearances |
| Dec 11, 1998 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITEK983697 · DIO | 510(k) clearances |
| Dec 11, 1998 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINESK983699 · DKZ | 510(k) clearances |
| Dec 11, 1998 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONEK983703 · DJR | 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
