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

Cleared Sep 28, 2010

K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL

K093137 · NDY

Chemistry · 358d

Cleared Apr 29, 2010

K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR

K091486 · DCF

Chemistry · 345d

Cleared Jul 25, 2002

K-ASSAY LP(A) ASSAY

K021660 · DFC

Chemistry · 66d

Cleared Dec 27, 1999

K-ASSAY MULTI-ANALYTE CALIBRATOR

K993853 · JIX

Chemistry · 45d

Cleared Nov 26, 1999

K-ASSAY APO A1/B CALIBRATOR SET

K993606 · JIX

Chemistry · 32d

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 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 Jan 30, 1991

DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS

K905829 · CEL

Chemistry · 30d