Cleared Traditional

SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN

K760143 · Oxford Laboratories, Inc. · Immunology

Jul 1976

Decision

21d

Days

Class 1

Risk

About This 510(k) Submission

K760143 is an FDA 510(k) clearance for the SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN, a Alpha-1-b-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code DEX), 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 866.5420.

Submission Details

510(k) Number	K760143 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	—