HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY— 510(k) K920221

Name: FDA 510(k) clearance K920221
Creator: U.S. Food and Drug Administration
Published: 1992-03-13

Substantially Equivalent

Akers Research Corp.

FDA 510(k) clearance K920221 for HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY, Substantially Equivalent on 1992-03-13. Applicant: Akers Research Corp.. Device class: 2.

Clearance details

Applicant: Akers Research Corp.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1992-01-16
Decision date: 1992-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thorofare, NJ, US

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K920222 — HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS1992-07-27
K920220 — HEALTHTEST RHEUMATOID FACTOR ASSAY1992-03-13

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