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
343 devices
151-175 of 343
Cleared Mar 18, 2005
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
K050585 · LRG
Microbiology · 11d
Cleared Feb 17, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16...
K043545 · LRG
Microbiology · 56d
Cleared Feb 15, 2005
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
K042735 · CFN
Immunology · 137d
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 Jan 07, 2005
EMIT II PLUS ECSTASY ASSAY
K043028 · DKZ
Toxicology · 65d
Cleared Dec 10, 2004
ENZYGNOST F+2 (MONOCLONAL) TEST KIT
K042687 · MIF
Hematology · 72d
Cleared Dec 02, 2004
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
K042941 · GIZ
Hematology · 38d
Cleared Dec 01, 2004
CONTROL PLASMA N, PROC CONTROL PLASMA
K042333 · GGN
Hematology · 93d
Cleared Nov 19, 2004
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
K042347 · NBC
Chemistry · 81d
Cleared Oct 28, 2004
EMIT CAFFEINE ASSAY
K042407 · KLS
Toxicology · 55d
Cleared Oct 21, 2004
CONTROL PLASMA N AND CONTROL PLASMA P
K042209 · GGN
Hematology · 66d
Cleared Aug 16, 2004
N LATEX CYSTATIN
K041878 · NDY
Chemistry · 35d
Cleared Aug 11, 2004
ADVANCED D-DIMER ASSAY
K041438 · DAP
Hematology · 71d
Cleared Jul 27, 2004
N APOLIPOPROTEIN STANDARD SERUM
K041870 · JIX
Chemistry · 18d
Cleared Jul 22, 2004
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS
K041150 · LRG
Microbiology · 80d
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 Apr 02, 2004
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN...
K031601 · LON
Microbiology · 317d
Cleared Mar 01, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948 · LRG
Microbiology · 73d
Cleared Feb 25, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE...
K033940 · LTT
Microbiology · 68d
Cleared Feb 20, 2004
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG...
K033809 · KLR
Toxicology · 74d
Cleared Feb 10, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K032706 · JWY
Microbiology · 161d
Cleared Feb 09, 2004
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713 · DIO
Toxicology · 75d
Cleared Jan 22, 2004
N HIGH SENSITIVITY CRP
K033908 · NQD
Chemistry · 36d

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