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

Cleared Feb 06, 2002

MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN...

K020185 · LON

Microbiology · 19d

Cleared Feb 06, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN...

K020209 · LON

Microbiology · 15d

Cleared Feb 06, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25,...

K020246 · LON

Microbiology · 13d

Cleared Feb 06, 2002

MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)

K020249 · LON

Microbiology · 13d

Cleared Jan 18, 2002

N LATEX LP(A)

K013128 · DFC

Chemistry · 121d

Cleared Jan 18, 2002

DADE THROMBOPLASTIN C PLUS

K013155 · GJS

Hematology · 119d

Cleared Nov 15, 2001

DIMENSION HAIC ASSAY, MODEL DF105

K011852 · LCP

Chemistry · 156d

Cleared Nov 09, 2001

BCS SYSTEM

K013114 · JPA

Hematology · 52d

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 Aug 22, 2001

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

K010418 · LTT

Microbiology · 191d

Cleared Aug 09, 2001

BCT SYSTEM

K011665 · JPA

Hematology · 71d

Cleared Jul 20, 2001

SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500

K011235 · JPA

Hematology · 88d

Cleared Jul 17, 2001

CYCLOSPORINE CALIBRATOR

K011112 · DLJ

Chemistry · 97d

Cleared Jul 09, 2001

TGL FLEX REAGENT CARTRIDGE

K010871 · CDT

Chemistry · 108d

Cleared Jun 21, 2001

DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA...

K002885 · JOZ

Hematology · 279d

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 May 01, 2001

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

K010494 · JPA

Hematology · 70d

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