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Dade Behring, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
343
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K093848PT-MULTI-CALIBRATOR, MODEL OPAT07December 20, 2010
K081161DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND July 28, 2008
K081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIJuly 21, 2008
K071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)June 25, 2008
K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOJune 4, 2008
K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYMarch 13, 2008
K073561DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALFebruary 26, 2008
K073072DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48BFebruary 21, 2008
K073055DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270January 3, 2008
K072965DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CONDecember 21, 2007
K072717DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210December 12, 2007
K071224DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATORNovember 13, 2007
K072435DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL HOctober 17, 2007
K072304FIBRINOGEN CALIBRATOR KITSeptember 19, 2007
K071980DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,HSeptember 11, 2007
K071811ETOH FLEX REAGENT CARTRIDGE (DF22)August 24, 2007
K071316MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEAugust 20, 2007
K071317MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREENAugust 20, 2007
K071834STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPMAugust 17, 2007
K071247N LATEX RF KITAugust 8, 2007