VIROGEN CMV ANTIBODY TEST— 510(k) K875101

Substantially Equivalent

Wampole Laboratories

FDA 510(k) clearance K875101 for VIROGEN CMV ANTIBODY TEST, Substantially Equivalent on 1988-03-01. Applicant: Wampole Laboratories. Device class: 1.

Clearance details

Applicant: Wampole Laboratories
Product code: Code LQO
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1987-12-10
Decision date: 1988-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.