Cleared Traditional

K-ASSAY LP(A) ASSAY

K021660 · Kamiya Biomedical Co. · Chemistry
Jul 2002
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K021660 is an FDA 510(k) clearance for the K-ASSAY LP(A) ASSAY, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on July 25, 2002, 66 days after receiving the submission on May 20, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K021660 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2002
Decision Date July 25, 2002
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5600

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