FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

296 results for "Roche Diagnostic Systems, Inc."
289–296 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Nov 05, 1984
ROCHE REAGENT FOR AST
K843109 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Oct 30, 1984
COBAS FP TDM CONTROLS
K843913 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Oct 17, 1984
COBAS-FIBRO
K842717 · JPA
Roche Diagnostic Systems, Inc.
Hematology · 96d
Cleared Oct 05, 1984
ROCHE REAGENT FOR ALT
K843111 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Sep 13, 1984
ROCHE STANDARDS FOR URIC ACID
K843112 · JIT
Roche Diagnostic Systems, Inc.
Chemistry · 37d
Cleared Sep 04, 1984
ROCHE STANDARDS FOR CHOLESTEROL
K843110 · JIS
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Feb 27, 1984
CK-NAC REAGENT
K834502 · CGS
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared May 09, 1983
COBAS STANDARDS FOR GLUCOSE & BUN
K831030 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 40d