Cleared Traditional

ALLERCOAT POSITIVE CONTROL SERUM

K823403 · Kallestad Laboratories, Inc. · Immunology
Dec 1982
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K823403 is an FDA 510(k) clearance for the ALLERCOAT POSITIVE CONTROL SERUM, 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 December 15, 1982, 30 days after receiving the submission on November 15, 1982. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K823403 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1982
Decision Date December 15, 1982
Days to Decision 30 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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