AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST— 510(k) K911362

Name: FDA 510(k) clearance K911362
Creator: U.S. Food and Drug Administration
Published: 1991-10-07

Substantially Equivalent

Amico Laboratories, Inc.

FDA 510(k) clearance K911362 for AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST, Substantially Equivalent on 1991-10-07. Applicant: Amico Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Amico Laboratories, Inc.
Product code: Code LJN
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1991-03-28
Decision date: 1991-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, US

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