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"
361–384 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
K031756 · CGN
Roche Diagnostics Corp.
Chemistry · 19d
Cleared May 22, 2003
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
K030845 · GJS
Roche Diagnostics Corp.
Hematology · 66d
Cleared May 12, 2003
ELECSYS LH CALSET II
K031299 · JIT
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
K030428 · DIP
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
K030213 · LDJ
Roche Diagnostics Corp.
Toxicology · 80d
Cleared Apr 01, 2003
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
K030740 · GHH
Roche Diagnostics Corp.
Hematology · 22d
Cleared Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · JFY
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Dec 06, 2002
ONLINE DAT II COCAINE II
K023281 · DIO
Roche Diagnostics Corp.
Toxicology · 66d
Cleared Nov 29, 2002
ELECSYS PROBNP CALCHECK
K020883 · JJX
Roche Diagnostics Corp.
Chemistry · 256d
Cleared Nov 25, 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
K023296 · DIO
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
K022516 · NBC
Roche Diagnostics Corp.
Chemistry · 112d
Cleared Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
K021190 · GJS
Roche Diagnostics Corp.
Hematology · 193d
Cleared Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND...
K020831 · GJS
Roche Diagnostics Corp.
Hematology · 224d
Cleared Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
K021218 · JFT
Roche Diagnostics Corp.
Chemistry · 145d
Cleared Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · JHY
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
K020672 · JZO
Roche Diagnostics Corp.
Immunology · 157d
Cleared Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
K022171 · NBW
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jul 16, 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512 · DJR
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jul 16, 2002
ONLINE DAT II METHADONE II
K021505 · DJR
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jul 12, 2002
ROCHE ONLINE GENTAMICIN
K020704 · LCD
Roche Diagnostics Corp.
Toxicology · 130d
Cleared Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021827 · NBW
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
K021513 · NBW
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448 · NBW
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Apr 16, 2002
ROCHE ONLINE THEOPHYLLINE
K020740 · KLS
Roche Diagnostics Corp.
Toxicology · 41d