WEST NILE VIRUS IGG INDIRECT ELISA— 510(k) K041068

Name: FDA 510(k) clearance K041068
Creator: U.S. Food and Drug Administration
Published: 2004-10-20

Substantially Equivalent

Panbio Limited

FDA 510(k) clearance K041068 for WEST NILE VIRUS IGG INDIRECT ELISA, Substantially Equivalent on 2004-10-20. Applicant: Panbio Limited. Device class: 2.

Clearance details

Applicant: Panbio Limited
Product code: Code NOP
Device class: Class 2
Regulation: 21 CFR 866.3940
Advisory panel: Microbiology
Date received: 2004-04-26
Decision date: 2004-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windsor, AU

Download summary PDF View on FDA.gov ↗

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