EBV VCA-P18 IGG ELISA— 510(k) K030863

Substantially Equivalent

Panbio Limited

FDA 510(k) clearance K030863 for EBV VCA-P18 IGG ELISA, Substantially Equivalent on 2003-06-27. Applicant: Panbio Limited. Device class: 1.

Clearance details

Applicant: Panbio Limited
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 2003-03-18
Decision date: 2003-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windsor, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.