EBV V VCA IGM ELISA KIT MODEL# EBM-200— 510(k) K020717

Name: FDA 510(k) clearance K020717
Creator: U.S. Food and Drug Administration
Published: 2002-06-13

Substantially Equivalent

Pan Bio Pty. , Ltd.

FDA 510(k) clearance K020717 for EBV V VCA IGM ELISA KIT MODEL# EBM-200, Substantially Equivalent on 2002-06-13. Applicant: Pan Bio Pty. , Ltd.. Device class: 1.

Clearance details

Applicant: Pan Bio Pty. , Ltd.
Product code: Code GNP
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 2002-03-05
Decision date: 2002-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windsor, AU

Download summary PDF View on FDA.gov ↗

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