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"
433–456 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Sep 05, 2000
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K002609 · DHR
Roche Diagnostics Corp.
Immunology · 14d
Cleared Sep 05, 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · CGA
Roche Diagnostics Corp.
Chemistry · 75d
Cleared Aug 22, 2000
ELECSYS HCG TEST SYSTEM
K002148 · DHA
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Aug 10, 2000
ELECSYS CA 15-3 CALCHECK
K002353 · JIS
Roche Diagnostics Corp.
Immunology · 8d
Cleared Aug 04, 2000
HDL CHOLESTEROL PLUS
K000568 · LBT
Roche Diagnostics Corp.
Chemistry · 164d
Cleared Jul 24, 2000
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
K993706 · JMM
Roche Diagnostics Corp.
Chemistry · 265d
Cleared Jul 13, 2000
ELECSYS INSULIN CALSET
K001906 · JIS
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Jul 12, 2000
ONTRAK TESTCUP 501, MODEL 3016633
K001421 · DKZ
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jul 10, 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
K001356 · DJC
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jun 29, 2000
ONTRAK TESTCUP 502, MODEL 3016641
K001417 · DKZ
Roche Diagnostics Corp.
Toxicology · 55d
Cleared Jun 28, 2000
ELECSYS INSULIN CALCHECK
K001846 · JJX
Roche Diagnostics Corp.
Chemistry · 9d
Cleared Jun 01, 2000
ELECSYS ANTI-TPO CALCHECK
K001014 · JJX
Roche Diagnostics Corp.
Immunology · 64d
Cleared May 18, 2000
THE CARDIAC READER SYSTEM
K000784 · MMI
Roche Diagnostics Corp.
Chemistry · 69d
Cleared May 17, 2000
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
K000155 · JZO
Roche Diagnostics Corp.
Immunology · 119d
Cleared Apr 27, 2000
ELECSYS THYROGLOBULIN CALCHECK
K001015 · JJX
Roche Diagnostics Corp.
Immunology · 29d
Cleared Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096 · LAF
Roche Diagnostics Corp.
Toxicology · 104d
Cleared Apr 13, 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164 · LDJ
Roche Diagnostics Corp.
Toxicology · 126d
Cleared Apr 07, 2000
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
K994165 · DIO
Roche Diagnostics Corp.
Toxicology · 120d
Cleared Apr 05, 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
K000534 · DHR
Roche Diagnostics Corp.
Immunology · 48d
Cleared Mar 21, 2000
ELECSYS CORTISOL CALCHECK
K000576 · JIX
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Mar 17, 2000
ELECSYS B-CROSSLAPS CALCHECK
K000042 · JJX
Roche Diagnostics Corp.
Chemistry · 71d
Cleared Mar 07, 2000
ELECSYS CORTISOL TEST SYSTEM
K000270 · JJY
Roche Diagnostics Corp.
Chemistry · 39d
Cleared Feb 23, 2000
ACCU-CHEK ADVANTAGE METER
K000365 · CGA
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Feb 23, 2000
ACCU-CHEK COMPLETE METER
K000364 · LFR
Roche Diagnostics Corp.
Chemistry · 19d