FDA 510(k) Applications Submitted by KAMIYA BIOMEDICAL CO.

FDA 510(k) Number Submission Date Device Name Applicant
K030687 03/05/2003 K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C KAMIYA BIOMEDICAL CO.
K050944 04/14/2005 K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET KAMIYA BIOMEDICAL CO.
K021660 05/20/2002 K-ASSAY LP(A) ASSAY KAMIYA BIOMEDICAL CO.
K022486 07/29/2002 K-ASSAY HS-CRP CONTROLS KAMIYA BIOMEDICAL CO.
K042241 08/19/2004 K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C KAMIYA BIOMEDICAL CO.
K023828 11/18/2002 K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR KAMIYA BIOMEDICAL CO.
K023853 11/19/2002 K-ASSAY LP(A) CONTROLS KAMIYA BIOMEDICAL CO.
K000361 02/04/2000 K-ASSAY AT-III KAMIYA BIOMEDICAL CO.
K990581 02/23/1999 DIRECT HDL-CHOLESTEROL REAGENT KAMIYA BIOMEDICAL CO.
K991166 04/07/1999 K-ASSAY MICROALBUMIN CALIBRATOR SET KAMIYA BIOMEDICAL CO.
K991210 04/09/1999 K-ASSAY CRP CALIBRATOR SET KAMIYA BIOMEDICAL CO.
K011079 04/09/2001 K-ASSAY HS-CRP CONTROLS KAMIYA BIOMEDICAL CO.
K991224 04/12/1999 K-ASSAY CRP KAMIYA BIOMEDICAL CO.
K991409 04/22/1999 K-ASSAY RHEUMATOID FACTOR KAMIYA BIOMEDICAL CO.
K991467 04/27/1999 K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET KAMIYA BIOMEDICAL CO.
K011780 06/07/2001 K-ASSAY C1-INA KAMIYA BIOMEDICAL CO.
K992311 07/09/1999 K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC KAMIYA BIOMEDICAL CO.
K992312 07/09/1999 K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B KAMIYA BIOMEDICAL CO.
K002558 08/14/2000 K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE KAMIYA BIOMEDICAL CO.
K992976 09/03/1999 K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR KAMIYA BIOMEDICAL CO.
K983130 09/08/1998 LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS KAMIYA BIOMEDICAL CO.
K983241 09/15/1998 ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS KAMIYA BIOMEDICAL CO.
K002948 09/21/2000 K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT KAMIYA BIOMEDICAL CO.
K993213 09/24/1999 K-ASSAY IGA KAMIYA BIOMEDICAL CO.
K993281 09/30/1999 K-ASSAY IGG KAMIYA BIOMEDICAL CO.
K993323 10/04/1999 K-ASSAY IGM KAMIYA BIOMEDICAL CO.
K993345 10/05/1999 K-ASSAY APO AI KAMIYA BIOMEDICAL CO.
K993354 10/05/1999 K-ASSAY APO B KAMIYA BIOMEDICAL CO.
K993437 10/12/1999 K-ASSAY C3 KAMIYA BIOMEDICAL CO.
K993441 10/12/1999 K-ASSAY ALPHA-1 AG KAMIYA BIOMEDICAL CO.
K993444 10/12/1999 K-ASSAY ALPHA-1 AT KAMIYA BIOMEDICAL CO.
K993480 10/14/1999 K-ASSAY HAPTOGLOBIN KAMIYA BIOMEDICAL CO.
K993481 10/14/1999 K-ASSAY C4 KAMIYA BIOMEDICAL CO.
K993482 10/14/1999 K-ASSAY FIBRINOGEN KAMIYA BIOMEDICAL CO.
K993537 10/19/1999 K-ASSAY TRANSFERRIN KAMIYA BIOMEDICAL CO.
K993606 10/25/1999 K-ASSAY APO A1/B CALIBRATOR SET KAMIYA BIOMEDICAL CO.
K993853 11/12/1999 K-ASSAY MULTI-ANALYTE CALIBRATOR KAMIYA BIOMEDICAL CO.
K984045 11/13/1998 RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS KAMIYA BIOMEDICAL CO.
K014293 12/28/2001 K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET KAMIYA BIOMEDICAL CO.
K012422 07/30/2001 K-ASSAY D-DIMER CONTROLS KAMIYA BIOMEDICAL CO.
K091486 05/19/2009 K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR KAMIYA BIOMEDICAL CO.
K093137 10/05/2009 K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL KAMIYA BIOMEDICAL CO.


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