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"
217–240 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Jul 15, 2008
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K081389 · NBW
Roche Diagnostics
Chemistry · 57d
Cleared Jun 20, 2008
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C...
K080811 · NDY
Roche Diagnostics Corp.
Chemistry · 88d
Cleared Jun 09, 2008
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · LGD
Roche Diagnostics Corp.
Microbiology · 179d
Cleared May 15, 2008
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
K080227 · MRZ
Roche Diagnostics Corp.
General Hospital · 106d
Cleared May 12, 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607 · JIX
Roche Diagnostics Corp.
Chemistry · 69d
Cleared Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · LCP
Roche Diagnostics Corp.
Chemistry · 206d
Cleared Mar 25, 2008
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET...
K080183 · DIF
Roche Diagnostics Corp.
Chemistry · 60d
Cleared Mar 21, 2008
COBAS LITHIUM
K063684 · NDW
Roche Diagnostics Corp.
Toxicology · 465d
Cleared Mar 06, 2008
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277 · DCN
Roche Diagnostics Corp.
Immunology · 106d
Cleared Feb 27, 2008
ELECSYS PROBNP II CALCHECK
K080147 · JJX
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Feb 05, 2008
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
K072437 · NBC
Roche Diagnostics
Chemistry · 166d
Cleared Jan 31, 2008
HANDHELD BASE UNIT
K072920 · GJS
Roche Diagnostics Corp.
Hematology · 108d
Cleared Oct 19, 2007
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · JGQ
Roche Diagnostics Corp.
Chemistry · 31d
Cleared Oct 05, 2007
ELECSYS CORTISOL TEST SYSTEM
K070788 · NHG
Roche Diagnostics
Chemistry · 197d
Cleared Sep 14, 2007
TOTAL PROTEIN URINE/CSF GEN.3
K071239 · JGQ
Roche Diagnostics
Chemistry · 134d
Cleared Sep 12, 2007
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
K071644 · DLZ
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Jul 30, 2007
COBAS C 111 ANALYZER
K071211 · CIT
Roche Diagnostics
Chemistry · 90d
Cleared Jul 13, 2007
ROCHE ELECSYS PTH TEST SYSTEM
K070709 · CEW
Roche Diagnostics Corp.
Chemistry · 121d
Cleared May 25, 2007
ACCU-CHEK PERFORMA SYSTEM
K070585 · NBW
Roche Diagnostics Corp.
Chemistry · 85d
Cleared May 11, 2007
COAGUCHEK XS PLUS SYSTEM
K071041 · GJS
Roche Diagnostics
Hematology · 29d
Cleared May 09, 2007
ACCU-CHEK SMART PIX
K062395 · NBW
Roche Diagnostics Corp.
Chemistry · 266d
Cleared Apr 17, 2007
AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K070172 · LSL
Roche Diagnostics Corporation
Microbiology · 89d
Cleared Apr 16, 2007
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K070174 · MKZ
Roche Diagnostics Corporation
Microbiology · 88d
Cleared Mar 20, 2007
ELECSYS PTH TEST SYSTEM
K070391 · CEW
Roche Diagnostics Corp.
Chemistry · 39d