Cleared Traditional

SERUM, IGA GOAT ANTI-HUMAN ACID

K760146 · Oxford Laboratories, Inc. · Immunology
Jul 1976
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K760146 is an FDA 510(k) clearance for the SERUM, IGA GOAT ANTI-HUMAN ACID, a Iga, Antigen, Antiserum, Control (Class II — Special Controls, product code CZP), submitted by Oxford Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976, 21 days after receiving the submission on June 29, 1976. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K760146 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1976
Decision Date July 20, 1976
Days to Decision 21 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

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

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