Cleared Traditional

H-103 IGG, H-104 IGA, H-105 IGM

K812821 · Immulok, Inc. · Immunology
Oct 1981
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K812821 is an FDA 510(k) clearance for the H-103 IGG, H-104 IGA, H-105 IGM, a Igg (gamma Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DFZ), submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1981, 19 days after receiving the submission on October 7, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K812821 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1981
Decision Date October 26, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DFZ — Igg (gamma Chain Specific), Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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