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"
337–360 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
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
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