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
51-75 of 343
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
K062375 · LRG
Microbiology · 72d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)
K063053 · LRG
Microbiology · 22d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)
K063064 · LRG
Microbiology · 20d
Cleared Oct 20, 2006
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID
K062705 · LON
Microbiology · 39d
Cleared Oct 13, 2006
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
K062773 · LTT
Microbiology · 25d
Cleared Oct 13, 2006
MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
K062923 · LRG
Microbiology · 15d
Cleared Oct 12, 2006
MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
K062927 · LRG
Microbiology · 14d
Cleared Oct 10, 2006
MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
K062777 · LTT
Microbiology · 22d
Cleared Oct 04, 2006
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE
K062035 · JIX
Immunology · 77d
Cleared Sep 22, 2006
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR,...
K061852 · CZW
Immunology · 84d
Cleared Sep 22, 2006
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
K062334 · JIX
Chemistry · 43d
Cleared Sep 19, 2006
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE
K061990 · DCF
Chemistry · 68d
Cleared Sep 19, 2006
MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
K062585 · LRG
Microbiology · 18d
Cleared Sep 19, 2006
MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID
K062596 · LRG
Microbiology · 18d
Cleared Sep 14, 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
K062162 · DKB
Toxicology · 48d
Cleared Sep 14, 2006
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
K062182 · DLJ
Toxicology · 45d
Cleared Sep 11, 2006
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061795 · NBC
Chemistry · 80d
Cleared Sep 11, 2006
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2...
K061802 · NQD
Chemistry · 76d
Cleared Sep 06, 2006
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL...
K061825 · DCN
Chemistry · 70d
Cleared Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
K062034 · JIX
Chemistry · 49d
Cleared Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
K062199 · DLJ
Toxicology · 36d
Cleared Sep 06, 2006
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K062316 · JIF
Chemistry · 28d
Cleared Sep 01, 2006
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
K062290 · LRG
Microbiology · 25d
Cleared Aug 29, 2006
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
K061839 · CIG
Chemistry · 61d
Cleared Aug 25, 2006
N LATEX CDT
K060677 · NAO
Chemistry · 164d

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