Cleared Traditional

CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)

K893467 · Immuno Concepts, Inc. · Microbiology
Jul 1989
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K893467 is an FDA 510(k) clearance for the CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST), a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II — Special Controls, product code LIN), submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on July 14, 1989, 72 days after receiving the submission on May 3, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K893467 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1989
Decision Date July 14, 1989
Days to Decision 72 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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