HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS— 510(k) K920222

Name: FDA 510(k) clearance K920222
Creator: U.S. Food and Drug Administration
Published: 1992-07-27

Substantially Equivalent

Akers Research Corp.

FDA 510(k) clearance K920222 for HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS, Substantially Equivalent on 1992-07-27. Applicant: Akers Research Corp.. Device class: 2.

Clearance details

Applicant: Akers Research Corp.
Product code: Code LJO
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1992-01-16
Decision date: 1992-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thorofare, NJ, US

Download summary PDF View on FDA.gov ↗

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