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Dade Behring, Inc.

FDA 510(k) & PMA Approved Devices — 343 products

Total Devices343
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K093848 PT-MULTI-CALIBRATOR, MODEL OPAT07GGN2010-12-20 View
510(k) K081161 DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYSTCFN2008-07-28 View
510(k) K081249 DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMDEB2008-07-21 View
510(k) K071603 DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)DHX2008-06-25 View
510(k) K071597 DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600LOJ2008-06-04 View
510(k) K073604 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MODCEC2008-03-13 View
510(k) K073561 DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATORCFN2008-02-26 View
510(k) K073072 DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48BJHM2008-02-21 View
510(k) K073055 DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270JFY2008-01-03 View
510(k) K072965 DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CONDBA2007-12-21 View
510(k) K072717 DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210JIT2007-12-12 View
510(k) K071224 DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATORCDD2007-11-13 View
510(k) K072435 DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL HJIX2007-10-17 View
510(k) K072304 FIBRINOGEN CALIBRATOR KITGFX2007-09-19 View
510(k) K071980 DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,HJJY2007-09-11 View
510(k) K071811 ETOH FLEX REAGENT CARTRIDGE (DF22)DIC2007-08-24 View
510(k) K071316 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREENLRG2007-08-20 View
510(k) K071317 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREENLON2007-08-20 View
510(k) K071834 STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPMNBC2007-08-17 View
510(k) K071247 N LATEX RF KITDHR2007-08-08 View
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