Cleared Traditional

K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL

K093137 · Kamiya Biomedical Co. · Chemistry
Sep 2010
Decision
358d
Days
Class 2
Risk

About This 510(k) Submission

K093137 is an FDA 510(k) clearance for the K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL, a Test, Cystatin C (Class II — Special Controls, product code NDY), submitted by Kamiya Biomedical Co. (Tukwila, US). The FDA issued a Cleared decision on September 28, 2010, 358 days after receiving the submission on October 5, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K093137 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2009
Decision Date September 28, 2010
Days to Decision 358 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NDY — Test, Cystatin C
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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