Cleared Traditional

CIC-C1Q EIA

K012576 · American Laboratory Products Co., Ltd. · Immunology
Jan 2002
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K012576 is an FDA 510(k) clearance for the CIC-C1Q EIA, a Complement C1q, Antigen, Antiserum, Control (Class II — Special Controls, product code DAK), submitted by American Laboratory Products Co., Ltd. (Windham, US). The FDA issued a Cleared decision on January 29, 2002, 173 days after receiving the submission on August 9, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K012576 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2001
Decision Date January 29, 2002
Days to Decision 173 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAK — Complement C1q, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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