Cleared Traditional

ALLERCOAT ALLERGEN DISCS

K842125 · Kallestad Laboratories, Inc. · Immunology
Jun 1984
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K842125 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 7, 1984, 9 days after receiving the submission on May 29, 1984. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K842125 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1984
Decision Date June 07, 1984
Days to Decision 9 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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