Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

296 results for "Roche Diagnostic Systems, Inc."
97–120 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Aug 09, 1993
ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
K933279 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Aug 05, 1993
COBAS(R) CORE IGE TOTAL EIA
K930890 · DGC
Roche Diagnostic Systems, Inc.
Immunology · 164d
Cleared Aug 03, 1993
ABUSCREEN ONLINE CONTROL
K931125 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 152d
Cleared Aug 03, 1993
ABUSCREEN ONLINE(R) CALIBRATORS
K931124 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 152d
Cleared Jul 22, 1993
ABUSCREEN CALIBRATION STANDARD
K932754 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 55d
Cleared Jul 22, 1993
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K932753 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 55d
Cleared Jul 06, 1993
ROCHE CARDIOTROL-CK
K930889 · JJT
Roche Diagnostic Systems, Inc.
Chemistry · 134d
Cleared May 26, 1993
COBAS CORE LH EIA
K930306 · CEP
Roche Diagnostic Systems, Inc.
Chemistry · 125d
Cleared May 26, 1993
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
K926441 · KLT
Roche Diagnostic Systems, Inc.
Chemistry · 154d
Cleared May 20, 1993
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
K926443 · KHQ
Roche Diagnostic Systems, Inc.
Chemistry · 148d
Cleared Apr 20, 1993
ROCHE ABUSCREEN ONTRAK FOR METHADONE
K930845 · DIW
Roche Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Apr 05, 1993
ROCHE OXI/FERM II
K923313 · LQM
Roche Diagnostic Systems, Inc.
Microbiology · 272d
Cleared Feb 25, 1993
COBAS-FP TDM CONTROLS
K930269 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 37d
Cleared Jan 27, 1993
ROCHE COBAS FUTURA GLUCOSE
K922811 · CFR
Roche Diagnostic Systems, Inc.
Chemistry · 231d
Cleared Jan 04, 1993
ROCHE REAGENT FOR AST
K924244 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 133d
Cleared Dec 28, 1992
ABUSCREEN ONLINE FOR COCAINE METABOLITE
K924113 · DLN
Roche Diagnostic Systems, Inc.
Toxicology · 137d
Cleared Dec 03, 1992
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
K925003 · LEG
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Nov 18, 1992
ROCHE REAGENT FOR GGT
K924246 · JQB
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Oct 22, 1992
ROCHE REAGENT FOR ALT
K924245 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Sep 11, 1992
ROCHE ENTEROTUBE II
K922588 · JSS
Roche Diagnostic Systems, Inc.
Microbiology · 102d
Cleared Aug 04, 1992
ROCHE ABUSCREEN ONLINNE CALIBRATORS
K923340 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Jul 28, 1992
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K921180 · JJQ
Roche Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Jul 09, 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Jun 19, 1992
COBAS CORE FERRITIN EIA
K920829 · JMG
Roche Diagnostic Systems, Inc.
Immunology · 116d