Cleared Traditional

THE CMV-IGM TEST

K860450 · Microbiological Research Corp. · Microbiology
May 1986
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K860450 is an FDA 510(k) clearance for the THE CMV-IGM TEST, a Antibody Igm,if, Cytomegalovirus Virus (Class II — Special Controls, product code LKQ), submitted by Microbiological Research Corp. (Bountiful, US). The FDA issued a Cleared decision on May 13, 1986, 98 days after receiving the submission on February 4, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K860450 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1986
Decision Date May 13, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LKQ — Antibody Igm,if, Cytomegalovirus Virus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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