Medical Device Manufacturer · US , Newark, , DE

Dade Behring, Inc. - FDA 510(k) Cleared Devices

343 submissions · 343 cleared · Since 1978
343
Total
343
Cleared
0
Denied
134 devices
51-75 of 134
Cleared Apr 14, 2006
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE...
K053577 · MMI
Chemistry · 113d
Cleared Apr 06, 2006
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
K060385 · MLM
Chemistry · 51d
Cleared Apr 06, 2006
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK...
K060548 · DHA
Chemistry · 36d
Cleared Apr 06, 2006
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
K060628 · CIG
Chemistry · 28d
Cleared Mar 29, 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · LPS
Chemistry · 177d
Cleared Mar 09, 2006
DIMENSION IRON CALIBRATOR
K060266 · JIS
Chemistry · 36d
Cleared Mar 09, 2006
THE EMIT 2000 TACROLIMUS CALIBRATORS
K060371 · JIT
Chemistry · 24d
Cleared Mar 08, 2006
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
K060264 · JIY
Chemistry · 35d
Cleared Mar 03, 2006
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
K053531 · CEC
Chemistry · 74d
Cleared Feb 27, 2006
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
K060090 · JLW
Chemistry · 46d
Cleared Feb 16, 2006
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
K053108 · DLJ
Chemistry · 104d
Cleared Feb 07, 2006
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
K053576 · JIT
Chemistry · 47d
Cleared Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
K053104 · JIS
Chemistry · 49d
Cleared Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
K053109 · NQD
Chemistry · 49d
Cleared Dec 09, 2005
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K053157 · LBS
Chemistry · 25d
Cleared Sep 08, 2005
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK
K051650 · JHX
Chemistry · 79d
Cleared Jul 11, 2005
DIMENSION VISTA INTEGRATED SYSTEM
K051087 · JJE
Chemistry · 74d
Cleared Feb 15, 2005
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK...
K043476 · NBC
Chemistry · 61d
Cleared Jan 18, 2005
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
K043546 · CDT
Chemistry · 26d
Cleared Nov 19, 2004
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
K042347 · NBC
Chemistry · 81d
Cleared Aug 16, 2004
N LATEX CYSTATIN
K041878 · NDY
Chemistry · 35d
Cleared Jul 27, 2004
N APOLIPOPROTEIN STANDARD SERUM
K041870 · JIX
Chemistry · 18d
Cleared Jul 20, 2004
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR,...
K041417 · NBC
Chemistry · 54d
Cleared Apr 08, 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133 · DKZ
Chemistry · 78d
Cleared Jan 22, 2004
N HIGH SENSITIVITY CRP
K033908 · NQD
Chemistry · 36d

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