Cleared Traditional

IBL C1Q-CIC CIA TEST

K032254 · Ibl GmbH · Immunology
Aug 2003
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K032254 is an FDA 510(k) clearance for the IBL C1Q-CIC CIA TEST, a Complement C1q, Antigen, Antiserum, Control (Class II — Special Controls, product code DAK), submitted by Ibl GmbH (East Stroudsburg, US). The FDA issued a Cleared decision on August 29, 2003, 38 days after receiving the submission on July 22, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K032254 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2003
Decision Date August 29, 2003
Days to Decision 38 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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