Cleared Traditional

CMV-VUE(TM) CMV ANTIGEN DETECTION KIT

K921616 · Incstar Corp. · Microbiology
Aug 1992
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K921616 is an FDA 510(k) clearance for the CMV-VUE(TM) CMV ANTIGEN DETECTION KIT, a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II — Special Controls, product code LIN), submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on August 11, 1992, 127 days after receiving the submission on April 6, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K921616 FDA.gov
FDA Decision Cleared SN
Date Received April 06, 1992
Decision Date August 11, 1992
Days to Decision 127 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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