Cleared Traditional

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM

K934594 · Ciba Corning Diagnostics Corp. · Immunology
Apr 1994
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K934594 is an FDA 510(k) clearance for the MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on April 21, 1994, 209 days after receiving the submission on September 24, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K934594 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1993
Decision Date April 21, 1994
Days to Decision 209 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DGC — Ige, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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