Cleared Traditional

OPUS(R) ANTI CMV-M

K913080 · Pb Diagnostics, Inc. · Microbiology
Oct 1991
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K913080 is an FDA 510(k) clearance for the OPUS(R) ANTI CMV-M, a Antibody Igm,if, Cytomegalovirus Virus (Class II — Special Controls, product code LKQ), submitted by Pb Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on October 28, 1991, 109 days after receiving the submission on July 11, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K913080 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1991
Decision Date October 28, 1991
Days to Decision 109 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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