Cleared Traditional

CMVGEN

K974456 · Instrumentation Laboratory CO · Microbiology
May 1998
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K974456 is an FDA 510(k) clearance for the CMVGEN, a Antigen, Iha, Cytomegalovirus (Class II — Special Controls, product code LJO), submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on May 1, 1998, 157 days after receiving the submission on November 25, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K974456 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 1997
Decision Date May 01, 1998
Days to Decision 157 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJO — Antigen, Iha, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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