Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

479 results for "Roche Diagnostics"
337–360 of 479
Cleared Aug 20, 2003
ELECSYS PRECICONTROL TROPONIN T
K031990 · JJX
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Aug 20, 2003
ELECYS SHBG CALCHECK
K031698 · JJX
Roche Diagnostics Corp.
Chemistry · 79d
Cleared Aug 06, 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
K031856 · DKB
Roche Diagnostics Corp.
Toxicology · 51d
Cleared Aug 05, 2003
TINA-QUANT CRP (LATEX)
K032336 · DCN
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Aug 05, 2003
PRECISET DAT PLUS I CALIBRATORS
K031775 · DKB
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Aug 05, 2003
ELECSYS SHBG IMMUNOASSAY
K031717 · CDZ
Roche Diagnostics Corp.
Chemistry · 63d
Cleared Jul 30, 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
K032089 · JJY
Roche Diagnostics Corp.
Chemistry · 23d
Cleared Jul 17, 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
K031879 · KHS
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jul 17, 2003
FERRITIN GENERATION 2
K031650 · DBF
Roche Diagnostics Corp.
Immunology · 50d
Cleared Jul 16, 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
K031880 · JIX
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Jul 09, 2003
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824 · CHH
Roche Diagnostics Corp.
Chemistry · 26d
Cleared Jul 03, 2003
ACCU-CHEK COMPACT TEST STRIP
K031755 · LFR
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
K031756 · CGN
Roche Diagnostics Corp.
Chemistry · 19d
Cleared May 22, 2003
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
K030845 · GJS
Roche Diagnostics Corp.
Hematology · 66d
Cleared May 12, 2003
ELECSYS LH CALSET II
K031299 · JIT
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
K030428 · DIP
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
K030213 · LDJ
Roche Diagnostics Corp.
Toxicology · 80d
Cleared Apr 01, 2003
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
K030740 · GHH
Roche Diagnostics Corp.
Hematology · 22d
Cleared Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · JFY
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Dec 06, 2002
ONLINE DAT II COCAINE II
K023281 · DIO
Roche Diagnostics Corp.
Toxicology · 66d
Cleared Nov 29, 2002
ELECSYS PROBNP CALCHECK
K020883 · JJX
Roche Diagnostics Corp.
Chemistry · 256d
Cleared Nov 25, 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
K023296 · DIO
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
K022516 · NBC
Roche Diagnostics Corp.
Chemistry · 112d
Cleared Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
K021190 · GJS
Roche Diagnostics Corp.
Hematology · 193d