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Kamiya Biomedical Co.

43 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL (K093137)Kamiya Biomedical Co.2010-09-28
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (K091486)Kamiya Biomedical Co.2010-04-29
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (K050944)Kamiya Biomedical Co.2005-12-23
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (K042241)Kamiya Biomedical Co.2004-12-10
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C (K030687)Kamiya Biomedical Co.2003-06-27
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR (K023828)Kamiya Biomedical Co.2003-02-04
K-ASSAY LP(A) CONTROLS (K023853)Kamiya Biomedical Co.2002-12-13
K-ASSAY HS-CRP CONTROLS (K022486)Kamiya Biomedical Co.2002-08-14
K-ASSAY LP(A) ASSAY (K021660)Kamiya Biomedical Co.2002-07-25
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET (K014293)Kamiya Biomedical Co.2002-02-19
K-ASSAY D-DIMER CONTROLS (K012422)Kamiya Biomedical Co.2001-08-21
K-ASSAY C1-INA (K011780)Kamiya Biomedical Co.2001-07-25
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT (K002948)Kamiya Biomedical Co.2001-05-18
K-ASSAY HS-CRP CONTROLS (K011079)Kamiya Biomedical Co.2001-05-16
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE (K002558)Kamiya Biomedical Co.2000-10-25
K-ASSAY AT-III (K000361)Kamiya Biomedical Co.2000-04-26
K-ASSAY MULTI-ANALYTE CALIBRATOR (K993853)Kamiya Biomedical Co.1999-12-27
K-ASSAY FIBRINOGEN (K993482)Kamiya Biomedical Co.1999-12-06
K-ASSAY IGM (K993323)Kamiya Biomedical Co.1999-11-30
K-ASSAY TRANSFERRIN (K993537)Kamiya Biomedical Co.1999-11-30
K-ASSAY C4 (K993481)Kamiya Biomedical Co.1999-11-29
K-ASSAY APO A1/B CALIBRATOR SET (K993606)Kamiya Biomedical Co.1999-11-26
K-ASSAY HAPTOGLOBIN (K993480)Kamiya Biomedical Co.1999-11-24
K-ASSAY C3 (K993437)Kamiya Biomedical Co.1999-11-24
K-ASSAY ALPHA-1 AT (K993444)Kamiya Biomedical Co.1999-11-24
K-ASSAY ALPHA-1 AG (K993441)Kamiya Biomedical Co.1999-11-24
K-ASSAY IGA (K993213)Kamiya Biomedical Co.1999-11-23
K-ASSAY IGG (K993281)Kamiya Biomedical Co.1999-11-09
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR (K992976)Kamiya Biomedical Co.1999-11-01
K-ASSAY APO B (K993354)Kamiya Biomedical Co.1999-10-28
K-ASSAY APO AI (K993345)Kamiya Biomedical Co.1999-10-25
K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC (K992311)Kamiya Biomedical Co.1999-09-13
K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B (K992312)Kamiya Biomedical Co.1999-09-13
DIRECT HDL-CHOLESTEROL REAGENT (K990581)Kamiya Biomedical Co.1999-06-18
K-ASSAY MICROALBUMIN CALIBRATOR SET (K991166)Kamiya Biomedical Co.1999-06-10
K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET (K991467)Kamiya Biomedical Co.1999-06-10
K-ASSAY RHEUMATOID FACTOR (K991409)Kamiya Biomedical Co.1999-06-09
K-ASSAY CRP (K991224)Kamiya Biomedical Co.1999-05-14
K-ASSAY CRP CALIBRATOR SET (K991210)Kamiya Biomedical Co.1999-05-11
RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS (K984045)Kamiya Biomedical Co.1999-01-25
LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS (K983130)Kamiya Biomedical Co.1998-09-29
ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS (K983241)Kamiya Biomedical Co.1998-09-29
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS (K905829)Kamiya Biomedical Co.1991-01-30

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Every clearance here is in the API, with alerts when new ones post.