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

Cleared Jan 12, 2004

DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR,...

K033525 · DCF

Chemistry · 66d

Cleared Dec 24, 2003

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

K033487 · MMI

Chemistry · 50d

Cleared Nov 07, 2003

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

K032697 · JIS

Chemistry · 66d

Cleared Oct 31, 2003

DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111

K032564 · LAN

Chemistry · 72d

Cleared Oct 31, 2003

DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

K032573 · LAR

Chemistry · 72d

Cleared Oct 30, 2003

DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A)...

K032798 · JHM

Chemistry · 51d

Cleared Jun 02, 2003

GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)

K031135 · CFR

Chemistry · 54d

Cleared Oct 16, 2002

CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

K023065 · MKW

Chemistry · 30d

Cleared May 09, 2002

DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131

K020724 · MRR

Chemistry · 64d

Cleared May 08, 2002

DIMENSION ALDL CALIBRATOR, MODEL DC131

K020723 · JIT

Chemistry · 63d

Cleared Jan 18, 2002

N LATEX LP(A)

K013128 · DFC

Chemistry · 121d

Cleared Nov 15, 2001

DIMENSION HAIC ASSAY, MODEL DF105

K011852 · LCP

Chemistry · 156d

Cleared Nov 09, 2001

N LP(A) STANDARD SY

K013126 · JIS

Chemistry · 51d

Cleared Oct 18, 2001

N LP(A) CONTROL SY

K013130 · JJX

Chemistry · 29d

Cleared Sep 28, 2001

MODIFICATION TO N PROTEIN STANDARD SL

K012470 · JIX

Chemistry · 57d

Cleared Sep 11, 2001

STRATUS CS TROPONIN I CALIBRATOR

K012233 · JIT

Chemistry · 57d

Cleared Sep 04, 2001

MODIFICATION TO N/T PROTEIN CONTROL SL

K012468 · JJY

Chemistry · 33d

Cleared Jul 17, 2001

CYCLOSPORINE CALIBRATOR

K011112 · DLJ

Chemistry · 97d

Cleared Jul 09, 2001

TGL FLEX REAGENT CARTRIDGE

K010871 · CDT

Chemistry · 108d

Cleared Jun 14, 2001

DIMENSION DRUG CALIBRATOR, MODEL DC22B

K011035 · JIX

Chemistry · 70d

Cleared Jun 07, 2001

DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132

K011033 · JIH

Chemistry · 63d

Cleared Apr 20, 2001

DIMENSION CTNI FLEX REAGENT CARTRIDGE

K010313 · MMI

Chemistry · 77d

Cleared Apr 20, 2001

DIMENSION CTNI CALIBRATOR

K010314 · JIT

Chemistry · 77d

Cleared Mar 16, 2001

DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137

K010206 · KHS

Chemistry · 52d

Cleared Mar 15, 2001

N PROTEIN STANDARD UY CALIBRATOR

K003501 · JIT

Chemistry · 122d