Cleared Traditional

CMV-EA MAB TEST

K912592 · Gull Laboratories, Inc. · Microbiology
Dec 1991
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K912592 is an FDA 510(k) clearance for the CMV-EA MAB TEST, a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II — Special Controls, product code LIN), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 4, 1991, 177 days after receiving the submission on June 10, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K912592 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 1991
Decision Date December 04, 1991
Days to Decision 177 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIN — Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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