Cleared Traditional

SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID

K760144 · Oxford Laboratories, Inc. · Immunology
Jul 1976
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K760144 is an FDA 510(k) clearance for the SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID, a Haptoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DAD), 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 866.5460.

Submission Details

510(k) Number K760144 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 DAD — Haptoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5460

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