Cleared Traditional

CMV TEST

K843138 · Microbiological Research Corp. · Microbiology
Jan 1985
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K843138 is an FDA 510(k) clearance for the CMV TEST, a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II — Special Controls, product code LIN), submitted by Microbiological Research Corp. (Bountiful, US). The FDA issued a Cleared decision on January 29, 1985, 173 days after receiving the submission on August 9, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K843138 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1984
Decision Date January 29, 1985
Days to Decision 173 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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