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"
193–216 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Mar 04, 2010
ELECSYS HCG STAT CALCHECK 5
K093700 · JJX
Roche Diagnostics Corp.
Chemistry · 93d
Cleared Feb 04, 2010
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS...
K092649 · NBC
Roche Diagnostics Corp.
Chemistry · 160d
Cleared Feb 03, 2010
AMPHETAMINES II
K083764 · DKZ
Roche Diagnostics Corp.
Chemistry · 412d
Cleared Dec 16, 2009
ELECSYS PROBNP II CALCHECK 5
K092169 · JJX
Roche Diagnostics
Chemistry · 148d
Cleared Dec 04, 2009
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
K092603 · CFR
Roche Diagnostics
Chemistry · 101d
Cleared Nov 16, 2009
ELECSYS HCG+B CALCHECK 5
K092168 · JJX
Roche Diagnostics
Chemistry · 118d
Cleared Nov 10, 2009
ELECSYS TOXO IGG CALCHECK 5
K092888 · JJX
Roche Diagnostics Corp.
Microbiology · 50d
Cleared Nov 03, 2009
ELECSYS PRECICONTROL THYROAB
K092320 · JJY
Roche Diagnostics
Chemistry · 91d
Cleared Oct 30, 2009
ELECSYS RUBELLA IGGA CALCHECK 5
K092585 · JJX
Roche Diagnostics
Microbiology · 67d
Cleared Oct 16, 2009
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
K083260 · DDR
Roche Diagnostics
Chemistry · 345d
Cleared Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
K091601 · JJX
Roche Diagnostics Corp.
Chemistry · 114d
Cleared Aug 19, 2009
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
K082699 · MMI
Roche Diagnostics
Chemistry · 338d
Cleared Jul 02, 2009
ELECSYS PRECICONTROL UNIVERSAL
K090541 · JJY
Roche Diagnostics
Chemistry · 122d
Cleared Jun 19, 2009
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE...
K082340 · CGN
Roche Diagnostics Corp.
Chemistry · 308d
Cleared Jun 18, 2009
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT...
K090939 · DKB
Roche Diagnostics
Chemistry · 76d
Cleared May 05, 2009
ELECSYS RUBELLA IGG CALCHECK
K090311 · JJX
Roche Diagnostics
Microbiology · 88d
Cleared Mar 18, 2009
C-REACTIVE PROTEIN (LATEX)
K083444 · DCN
Roche Diagnostics Corp.
Immunology · 117d
Cleared Feb 12, 2009
ELECSYS TOXO IGG CALCHECK
K083655 · JJX
Roche Diagnostics
Microbiology · 64d
Cleared Jan 16, 2009
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
K081193 · CIG
Roche Diagnostics
Chemistry · 263d
Cleared Dec 05, 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · LFX
Roche Diagnostics Corp.
Microbiology · 445d
Cleared Oct 28, 2008
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K082595 · LZG
Roche Diagnostics
General Hospital · 50d
Cleared Sep 11, 2008
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
K081338 · NHX
Roche Diagnostics
Immunology · 121d
Cleared Aug 22, 2008
ELECSYS ANTI-TSHR CALCHECK
K080643 · JJX
Roche Diagnostics
Chemistry · 169d
Cleared Jul 28, 2008
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · JZO
Roche Diagnostics Corp.
Immunology · 196d