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"
409–432 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared May 29, 2001
TINA-QUANT D-DIMER TEST SYSTEM
K011143 · GHH
Roche Diagnostics Corp.
Hematology · 46d
Cleared May 10, 2001
CRP HS TEST SYSTEM
K003400 · DCN
Roche Diagnostics Corp.
Immunology · 190d
Cleared May 01, 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
K003064 · DDG
Roche Diagnostics Corp.
Immunology · 211d
Cleared Apr 26, 2001
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT...
K004010 · LFR
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Mar 28, 2001
ELECSYSCA 15-3 II ASSAY
K010588 · MOI
Roche Diagnostics Corp.
Immunology · 29d
Cleared Mar 19, 2001
ACCU-CHEK INFORM METER
K003846 · LFR
Roche Diagnostics Corp.
Chemistry · 97d
Cleared Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
K002706 · DAP
Roche Diagnostics Corp.
Hematology · 198d
Cleared Mar 07, 2001
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362 · LFR
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Mar 01, 2001
ELECSYS TESTOSTERONE CALSET II
K003411 · JIT
Roche Diagnostics Corp.
Chemistry · 119d
Cleared Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
K003865 · DKZ
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Feb 14, 2001
ELECSYS HCG+B CALCHECK
K010237 · JJX
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jan 26, 2001
ELECSYS FSH CALSET II
K003409 · JIT
Roche Diagnostics Corp.
Chemistry · 85d
Cleared Jan 25, 2001
ELECSYS HCG STAT CLASET II
K003941 · JIS
Roche Diagnostics Corp.
Chemistry · 35d
Cleared Jan 17, 2001
ELECSYS DHEA-S
K003174 · JKC
Roche Diagnostics Corp.
Chemistry · 99d
Cleared Jan 12, 2001
ELECSYS CA 125 II CALSET
K003969 · JIS
Roche Diagnostics Corp.
Immunology · 21d
Cleared Jan 12, 2001
CA 125 II CALCHECK
K003967 · JJX
Roche Diagnostics Corp.
Immunology · 21d
Cleared Dec 20, 2000
ELECSYS DHEA-S CALCHECK
K003772 · JJX
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Dec 18, 2000
ROCHE DIAGNOSTICS CK-MB
K003158 · JHW
Roche Diagnostics Corp.
Chemistry · 69d
Cleared Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120 · LCP
Roche Diagnostics Corp.
Hematology · 74d
Cleared Dec 14, 2000
ELECSYS HCG AND BETA TEST SYSTEM
K003178 · DHA
Roche Diagnostics Corp.
Chemistry · 64d
Cleared Nov 16, 2000
CREATININE PLUS
K003261 · JFY
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Oct 23, 2000
ELECSYS CA 15-3 TEST SYSTEM
K001468 · MOI
Roche Diagnostics Corp.
Immunology · 166d
Cleared Oct 05, 2000
ELECSYS DHEA-S CALSET
K002760 · JIS
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Sep 06, 2000
COAGUCHEK S SYSTEM, MODEL 2138280
K994349 · JPA
Roche Diagnostics Corp.
Hematology · 258d