Cleared Traditional

ALLERCOAT ALLERGEN DISCS

K831326 · Kallestad Laboratories, Inc. · Immunology
Jun 1983
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K831326 is an FDA 510(k) clearance for the ALLERCOAT ALLERGEN DISCS, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983, 38 days after receiving the submission on April 25, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K831326 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1983
Decision Date June 02, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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