CYTOMEGALOVIRUS (CMV) ELISA— 510(k) K904456

Substantially Equivalent

Virotech, Inc.

FDA 510(k) clearance K904456 for CYTOMEGALOVIRUS (CMV) ELISA, Substantially Equivalent on 1991-04-03. Applicant: Virotech, Inc.. Device class: 2.

Clearance details

Applicant: Virotech, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1990-10-01
Decision date: 1991-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Caldwell, NJ, US

Download summary PDF View on FDA.gov ↗

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