Cleared Traditional

LP(A)-LATEX SEIKEN ASSAY KIT

K013359 · Denka Seiken'S · Chemistry
Mar 2002
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K013359 is an FDA 510(k) clearance for the LP(A)-LATEX SEIKEN ASSAY KIT, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Denka Seiken'S (Tokyo, JP). The FDA issued a Cleared decision on March 8, 2002, 149 days after receiving the submission on October 10, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K013359 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2001
Decision Date March 08, 2002
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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