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
251-275 of 343
Cleared Mar 15, 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501 · JIT
Chemistry · 122d
Cleared Mar 14, 2001
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061 · CEM
Chemistry · 65d
Cleared Mar 13, 2001
N LATEX CYSTATIN C
K003503 · NDY
Chemistry · 120d
Cleared Feb 28, 2001
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963 · LTJ
Immunology · 68d
Cleared Feb 20, 2001
THROMBOREL S
K003870 · GJS
Hematology · 67d
Cleared Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · JIT
Chemistry · 28d
Cleared Feb 14, 2001
RCRP FLEX REAGENT CARTRIDGE
K003419 · DCN
Immunology · 104d
Cleared Jan 25, 2001
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG,...
K003696 · DHA
Chemistry · 56d
Cleared Dec 05, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
K003209 · DJG
Toxicology · 53d
Cleared Nov 27, 2000
N/T PROTEIN CONTROL SL
K002852 · JJY
Chemistry · 75d
Cleared Nov 20, 2000
N LATEX B2-MICROGLOBULIN
K002731 · JZG
Immunology · 80d
Cleared Nov 16, 2000
BEHRING COAGULATION SYSTEM, MODEL BCS
K002080 · JPA
Hematology · 129d
Cleared Oct 11, 2000
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL...
K002551 · LEG
Chemistry · 55d
Cleared Oct 11, 2000
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · LDP
Chemistry · 55d
Cleared Oct 05, 2000
N PROTEIN STANDARD SL
K002804 · JIX
Chemistry · 27d
Cleared Sep 26, 2000
BN PROSPEC SYSTEM
K001647 · JZW
Immunology · 119d
Cleared Sep 26, 2000
PROTEIN C REAGENT
K002541 · GGP
Hematology · 41d
Cleared Aug 04, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K001645 · GKP
Hematology · 66d
Cleared Jun 21, 2000
BEHRING COAGULATION TIMER ANALYZER (BCT)
K001064 · JPA
Hematology · 79d
Cleared Jun 20, 2000
DADE BEHRING COAGULATION ANALYZER (BCT)
K001067 · JPA
Hematology · 78d
Cleared May 26, 2000
BEHRING COAGULATION SYSTEM (BCS)
K000973 · JPA
Hematology · 60d
Cleared May 24, 2000
CONTROL PLASMA N
K001256 · GIZ
Hematology · 35d
Cleared May 11, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K001145 · GKP
Hematology · 31d
Cleared Apr 25, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K000649 · GGP
Hematology · 57d
Cleared Apr 17, 2000
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458 · JXM
Toxicology · 66d

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