Search FDA 510(k) Devices

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

479 results for "Roche Diagnostics"
73–96 of 479
Cleared Jun 13, 2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
K160729 · PMT
Roche Diagnostics
Microbiology · 89d
Cleared May 25, 2016
Creatine Kinase
K160570 · JHS
Roche Diagnostics Operations (Rdo)
Chemistry · 86d
Cleared Apr 27, 2016
Elecsys Cortisol II, Cortisol II CalSet
K152227 · JFT
Roche Diagnostics
Chemistry · 264d
Cleared Apr 08, 2016
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
K153301 · KXT
Roche Diagnostics
Chemistry · 147d
Cleared Jan 08, 2016
ONLINE TDM Vancomycin Gen.3
K152245 · LEH
Roche Diagnostics Operations (Rdo)
Chemistry · 151d
Cleared Oct 22, 2015
Carbamazepine Gen 4
K151578 · KLT
Roche Diagnostics Operations (Rdo)
Toxicology · 133d
Cleared Oct 02, 2015
Elecsys Progesterone III CalSet
K152526 · JIT
Roche Diagnostics
Chemistry · 29d
Cleared Sep 24, 2015
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
K151786 · CDD
Roche Diagnostics
Chemistry · 85d
Cleared Aug 13, 2015
Accu-Chek FlexLink Plus infusion set
K143446 · FPA
Roche Diagnostics GmbH
General Hospital · 254d
Cleared May 01, 2015
Elecsys Progesterone III Cal Check 5
K150955 · JJX
Roche Diagnostics
Chemistry · 22d
Cleared Mar 16, 2015
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
K141929 · NDC
Roche Diagnostics Corporation
General Hospital · 243d
Cleared Mar 03, 2015
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K141867 · NBW
Roche Diagnostics
Chemistry · 236d
Cleared Jan 28, 2015
LDLC3 LDL-Cholesterol Gen.3
K143691 · LBR
Roche Diagnostics Operations (Rdo)
Chemistry · 35d
Cleared Dec 19, 2014
Elecsys T-Uptake Calset
K143342 · JIT
Roche Diagnostics
Chemistry · 28d
Cleared Dec 17, 2014
ACCU-CHEK AVIVA EXPERT SYSTEM
K142089 · LFR
Roche Diagnostics Corporation
Chemistry · 138d
Cleared Dec 16, 2014
Elecsys Estradiol III Calcheck
K143284 · JJX
Roche Diagnostics
Chemistry · 29d
Cleared Dec 09, 2014
TOTAL PROTEIN URINE/CSF GEN.3
K141925 · JIQ
Roche Diagnostics Operations (Rdo)
Chemistry · 146d
Cleared Nov 25, 2014
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
K141928 · DKB
Roche Diagnostics Operations (Rdo)
Chemistry · 132d
Cleared Oct 24, 2014
ELECYS CMV IGM IMMUNOASSAY
K142133 · LFZ
Roche Diagnostics
Microbiology · 81d
Cleared Oct 17, 2014
ELECSYS FOLATE III
K141426 · CGN
Roche Diagnostics
Chemistry · 140d
Cleared Sep 05, 2014
ELECSYS ESTRADIOL III CALCHECK 5
K142127 · JJX
Roche Diagnostics
Chemistry · 32d
Cleared Aug 29, 2014
ACCU-CHEK Performa Blood Glucose Monitoring System
K133741 · NBW
Roche Diagnostics
Chemistry · 263d
Cleared Aug 12, 2014
Elecsys Estradiol III CalSet
K142021 · JIT
Roche Diagnostics
Chemistry · 18d
Cleared Jul 17, 2014
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR,...
K141143 · NDY
Roche Diagnostics
Chemistry · 76d