Kamiya Biomedical Co. - FDA 510(k) Cleared Devices

Cleared Nov 24, 1999

K-ASSAY HAPTOGLOBIN

K993480 · DAD

Immunology · 41d

Cleared Nov 23, 1999

K-ASSAY IGA

K993213 · CFF

Immunology · 60d

Cleared Nov 09, 1999

K-ASSAY IGG

K993281 · DEW

Immunology · 40d

Cleared Nov 01, 1999

K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR

K992976 · DDR

Chemistry · 59d

Cleared Oct 28, 1999

K-ASSAY APO B

K993354 · DER

Chemistry · 23d

Cleared Oct 25, 1999

K-ASSAY APO AI

K993345 · DER

Chemistry · 20d

Cleared Sep 13, 1999

K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC

K992311 · DCK

Chemistry · 66d

Cleared Sep 13, 1999

K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B

K992312 · DCK

Immunology · 66d

Cleared Jun 18, 1999

DIRECT HDL-CHOLESTEROL REAGENT

K990581 · LBS

Chemistry · 115d

Cleared Jun 10, 1999

K-ASSAY MICROALBUMIN CALIBRATOR SET

K991166 · JIX

Chemistry · 64d

Cleared Jun 10, 1999

K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET

K991467 · DHR

Immunology · 44d

Cleared Jun 09, 1999

K-ASSAY RHEUMATOID FACTOR

K991409 · DHR

Immunology · 48d

Cleared May 14, 1999

K-ASSAY CRP

K991224 · DCK

Immunology · 32d

Cleared May 11, 1999

K-ASSAY CRP CALIBRATOR SET

K991210 · DCK

Immunology · 32d

Cleared Jan 25, 1999

RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS

K984045 · DHR

Immunology · 73d

Cleared Sep 29, 1998

LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS

K983130 · JJY

Immunology · 21d

Cleared Sep 29, 1998

ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS

K983241 · JJY

Immunology · 14d

Cleared Jan 30, 1991

DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS

K905829 · CEL

Chemistry · 30d