EBV EA-D IGG ELISA KIT, MODEL EBG-100— 510(k) K021793

Name: FDA 510(k) clearance K021793
Creator: U.S. Food and Drug Administration
Published: 2002-09-27

Substantially Equivalent

Pan Bio Pty. , Ltd.

FDA 510(k) clearance K021793 for EBV EA-D IGG ELISA KIT, MODEL EBG-100, Substantially Equivalent on 2002-09-27. Applicant: Pan Bio Pty. , Ltd.. Device class: 1.

Clearance details

Applicant: Pan Bio Pty. , Ltd.
Product code: Code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 2002-05-31
Decision date: 2002-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, Queensland, AU

Download summary PDF View on FDA.gov ↗

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