Cleared Traditional

THE GOLDEN QUAD TEST (CMV)

K861123 · Microbiological Research Corp. · Microbiology
Feb 1987
Decision
314d
Days
Class 2
Risk

About This 510(k) Submission

K861123 is an FDA 510(k) clearance for the THE GOLDEN QUAD TEST (CMV), a Antiserum, Cf, Cytomegalovirus (Class II — Special Controls, product code GQI), submitted by Microbiological Research Corp. (Bountiful, US). The FDA issued a Cleared decision on February 2, 1987, 314 days after receiving the submission on March 25, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K861123 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1986
Decision Date February 02, 1987
Days to Decision 314 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQI — Antiserum, Cf, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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