FDA applicant
Roche Diagnostic Systems, Inc.
FDA records 296 decisions for Roche Diagnostic Systems, Inc. (Montclair, NJ) from 1983 to 1999: 296 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and DIF (Drug Mixture Control Materials). Its devices cite 66 predicates, 38 of them its own earlier devices. 16 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Roche Diagnostic Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Roche Diagnostic Systems, Inc. since 2007.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Roche Diagnostic Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Roche”
FDA records each applicant name separately; these may or may not be the same firm.