Cleared Traditional

LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115

K024219 · Bio-Rad · Immunology
Jan 2003
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K024219 is an FDA 510(k) clearance for the LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115, a Anti-sm Antibody, Antigen And Control (Class II — Special Controls, product code LKP), submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on January 15, 2003, 23 days after receiving the submission on December 23, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K024219 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2002
Decision Date January 15, 2003
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LKP — Anti-sm Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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