Kamiya Biomedical Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
45
Inspections
0
Compliance Actions
0

Known Names

kamiya biomedical company, kamiya biomedical

Recent 510(k) Clearances

K-NumberDeviceDate
K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)May 20, 2020
K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORMay 24, 2012
K093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLSeptember 28, 2010
K091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORApril 29, 2010
K050944K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SETDecember 23, 2005
K042241K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CDecember 10, 2004
K030687K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091CJune 27, 2003
K023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASFebruary 4, 2003
K023853K-ASSAY LP(A) CONTROLSDecember 13, 2002
K022486K-ASSAY HS-CRP CONTROLSAugust 14, 2002
K021660K-ASSAY LP(A) ASSAYJuly 25, 2002
K014293K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SETFebruary 19, 2002
K012422K-ASSAY D-DIMER CONTROLSAugust 21, 2001
K011780K-ASSAY C1-INAJuly 25, 2001
K002948K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENTMay 18, 2001
K011079K-ASSAY HS-CRP CONTROLSMay 16, 2001
K002558K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGEOctober 25, 2000
K000361K-ASSAY AT-IIIApril 26, 2000
K993853K-ASSAY MULTI-ANALYTE CALIBRATORDecember 27, 1999
K993482K-ASSAY FIBRINOGENDecember 6, 1999