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

Cleared Apr 14, 2000

URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A

K000460 · DKZ

Toxicology · 63d

Cleared Apr 14, 2000

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A

K000464 · DJG

Toxicology · 63d

Cleared Apr 14, 2000

URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A

K000467 · DIO

Toxicology · 63d

Cleared Apr 06, 2000

URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A

K000461 · LDJ

Toxicology · 55d

Cleared Apr 06, 2000

URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A

K000462 · LCM

Toxicology · 55d

Cleared Apr 05, 2000

URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A

K000466 · DJR

Toxicology · 54d

Cleared Apr 03, 2000

URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A

K000459 · DIS

Toxicology · 52d

Cleared Mar 03, 2000

FIBRINOGEN CALIBRATOR KIT

K994341 · GFX

Hematology · 71d

Cleared Mar 01, 2000

DIMENSION SPECIAL PROTEIN CALIBRATOR

K994291 · JIT

Immunology · 71d

Cleared Mar 01, 2000

DIMENSION C4 FLEX REAGENT CARTRIDGE

K994293 · DBI

Immunology · 71d

Cleared Mar 01, 2000

DIMENSION C3 FLEX REAGENT CARTRIDGE

K994296 · CZW

Immunology · 71d

Cleared Feb 04, 2000

DIMENSION TRNF FLEX REAGENT CARTRIDGE

K994294 · DDG

Immunology · 45d

Cleared Jan 28, 2000

ADVANCED D-DIMER

K992957 · DAP

Hematology · 148d

Cleared Jan 28, 2000

TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE

K994115 · JMO

Chemistry · 53d

Cleared Jan 20, 2000

DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR

K994114 · JIS

Chemistry · 45d

Cleared Jan 11, 2000

BEHRING COAGULATION SYSTEM (BCS)

K992959 · JPA

Hematology · 131d

Cleared Dec 07, 1999

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

K993299 · GKP

Hematology · 67d

Cleared Nov 30, 1999

APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH

K993310 · JJY

Chemistry · 57d

Cleared Nov 23, 1999

N LATEX FERRITIN

K993273 · DBF

Immunology · 54d

Cleared Nov 09, 1999

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

K993174 · GKP

Hematology · 48d

Cleared Oct 25, 1999

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY

K991385 · DCK

Immunology · 187d

Cleared Sep 21, 1999

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500

K992423 · GKP

Hematology · 62d

Cleared Sep 21, 1999

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500

K992763 · GKP

Hematology · 35d

Cleared Sep 17, 1999

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

K992321 · GKP

Hematology · 67d

Cleared Aug 02, 1999

N LATEX STFR REAGENT

K991157 · DDG

Immunology · 117d