Search FDA 510(k) Devices

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

479 results for "Roche Diagnostics"
385–408 of 479
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396 · DKZ
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Nov 02, 2001
OMNI C ANALYZER
K013373 · CEM
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397 · JIL
Roche Diagnostics Corp.
Chemistry · 61d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012393 · DDG
Roche Diagnostics Corp.
Immunology · 54d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012371 · DDG
Roche Diagnostics Corp.
Immunology · 55d
Cleared Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399 · JIT
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Aug 09, 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · NBW
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · LBS
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · MRR
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226 · JIX
Roche Diagnostics Corp.
Chemistry · 66d
Cleared Jun 25, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · JFJ
Roche Diagnostics Corp.
Chemistry · 91d
Cleared Jun 20, 2001
ACCU-CHEK ACTIVE SYSTEM
K011738 · NBW
Roche Diagnostics Corp.
Chemistry · 15d
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