Search FDA 510(k) Devices

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

479 results for "Roche Diagnostics"
313–336 of 479
Cleared Feb 13, 2004
ELECSYS C-PEPTIDE CALSET
K033873 · JIX
Roche Diagnostics Corp.
Toxicology · 60d
Cleared Jan 12, 2004
ROCHE ONLINE TDM LIDOCAINE
K032334 · KLR
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Jan 12, 2004
ROCHE ONLINE TDM QUINIDINE
K032332 · LBZ
Roche Diagnostics Corp.
Toxicology · 167d
Cleared Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
K033937 · JJY
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Dec 18, 2003
FACTOR II (PROTHROMBIN) G20210A KIT
K033612 · NPR
Roche Diagnostics Corp.
Pathology · 31d
Cleared Dec 17, 2003
LIGHTCYCLER INSTRUMENT VERSION 1.2
K033734 · JJF
Roche Diagnostics Corp.
Chemistry · 19d
Not Cleared Dec 17, 2003
FACTOR V LEIDEN KIT
DEN030005 · NPQ
Roche Diagnostics Corp.
Pathology · 9d
Cleared Dec 15, 2003
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K033306 · DKB
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Dec 05, 2003
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · LBS
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Dec 02, 2003
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
K033246 · DLJ
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Nov 24, 2003
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · KHE
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Nov 20, 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
K033501 · JIX
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Nov 12, 2003
ELECSYS PROBNP IMMUNOASSAY
K032646 · NBC
Roche Diagnostics Corp.
Chemistry · 77d
Cleared Oct 17, 2003
ROCHE DIAGNOSTICS OMNI S ANALYZER
K032311 · CEM
Roche Diagnostics Corp.
Chemistry · 81d
Cleared Oct 16, 2003
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
K033009 · CIX
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Oct 14, 2003
COBAS INTEGRA ALP IFCC GEN.2
K033185 · CJE
Roche Diagnostics Corp.
Chemistry · 13d
Cleared Oct 14, 2003
PRECISET DAT AMPHETAMINE CALIBRATORS
K033165 · DLJ
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Oct 10, 2003
ONLINE TDM AMIKA
K032279 · KLP
Roche Diagnostics Corp.
Toxicology · 78d
Cleared Oct 08, 2003
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437 · JIL
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Sep 17, 2003
ONLINE TDM CARBAMAZEPINE
K031902 · KLT
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Sep 12, 2003
ACCU-CHEK ADVANTAGE SYSTEM
K032552 · NBW
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Sep 10, 2003
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535 · DHR
Roche Diagnostics Corp.
Immunology · 23d
Cleared Aug 22, 2003
ROCHE ONLINE TDM VALPROIC ACID
K032049 · LEG
Roche Diagnostics Corp.
Toxicology · 51d
Cleared Aug 21, 2003
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
K032377 · KHS
Roche Diagnostics Corp.
Chemistry · 20d