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

491 results for "Roche Diagnostics"
97–120 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
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
Cleared Jun 06, 2014
CA 125 II CALSET II
K140112 · JIT
Roche Diagnostics
Immunology · 142d
Cleared May 22, 2014
ISE INDIRECT NA, K, C1 FOR GEN 2
K140373 · JGS
Roche Diagnostics
Chemistry · 97d
Cleared May 08, 2014
ELECSYS CK-MB STAT IMMUNOASSAY
K140404 · JHY
Roche Diagnostics
Chemistry · 79d
Cleared Apr 29, 2014
ACCU-CHEK AVIVA PLUS SYSTEM
K133862 · NBW
Roche Diagnostics Corporation
Chemistry · 131d
Cleared Mar 27, 2014
ELECSYS PRECICONTROL TS
K140534 · JJX
Roche Diagnostics
Chemistry · 23d
Cleared Feb 28, 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
K131605 · LFZ
Roche Diagnostics
Microbiology · 270d
Cleared Jan 27, 2014
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
K131244 · CEC
Roche Diagnostics
Chemistry · 271d
Cleared Dec 18, 2013
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
K132418 · JGS
Roche Diagnostics
Chemistry · 138d
Cleared Dec 04, 2013
ELECSYS CALCITONIN
K132828 · JKR
Roche Diagnostics
Chemistry · 86d
Cleared Nov 26, 2013
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM...
K133330 · JIX
Roche Diagnostics
Chemistry · 25d
Cleared Nov 22, 2013
ELECSYS CK-MB CALCHECK 5
K133284 · JJX
Roche Diagnostics
Chemistry · 28d
Cleared Oct 18, 2013
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571 · JHY
Roche Diagnostics
Chemistry · 64d