Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

479 results for "Roche Diagnostics"
409–432 of 479
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
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