Cleared Traditional

HUMAN ALPHA, ACID GLYCOPROTEIN

K791341 · Beckman Instruments, Inc. · Immunology
Aug 1979
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K791341 is an FDA 510(k) clearance for the HUMAN ALPHA, ACID GLYCOPROTEIN, a Alpha-1-b-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code DEX), submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979, 31 days after receiving the submission on July 16, 1979. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5420.

Submission Details

510(k) Number K791341 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1979
Decision Date August 16, 1979
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DEX — Alpha-1-b-glycoprotein, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5420

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