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Kamiya Biomedical Co.

FDA 510(k) & PMA Approved Devices — 43 products

Total Devices43
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K093137 K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLNDY2010-09-28 View
510(k) K091486 K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORDCF2010-04-29 View
510(k) K050944 K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SETDBF2005-12-23 View
510(k) K042241 K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CDGC2004-12-10 View
510(k) K030687 K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091CDAP2003-06-27 View
510(k) K023828 K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBRDCK2003-02-04 View
510(k) K023853 K-ASSAY LP(A) CONTROLSDFC2002-12-13 View
510(k) K022486 K-ASSAY HS-CRP CONTROLSDCK2002-08-14 View
510(k) K021660 K-ASSAY LP(A) ASSAYDFC2002-07-25 View
510(k) K014293 K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SETDBF2002-02-19 View
510(k) K012422 K-ASSAY D-DIMER CONTROLSGGC2001-08-21 View
510(k) K011780 K-ASSAY C1-INADBA2001-07-25 View
510(k) K002948 K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENTDAP2001-05-18 View
510(k) K011079 K-ASSAY HS-CRP CONTROLSDCK2001-05-16 View
510(k) K002558 K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGEDCK2000-10-25 View
510(k) K000361 K-ASSAY AT-IIIJBQ2000-04-26 View
510(k) K993853 K-ASSAY MULTI-ANALYTE CALIBRATORJIX1999-12-27 View
510(k) K993482 K-ASSAY FIBRINOGENGIS1999-12-06 View
510(k) K993537 K-ASSAY TRANSFERRINDDG1999-11-30 View
510(k) K993323 K-ASSAY IGMCFF1999-11-30 View
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