WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M— 510(k) K031952

Name: FDA 510(k) clearance K031952
Creator: U.S. Food and Drug Administration
Published: 2003-10-22

Substantially Equivalent

Focus Technologies, Inc.

FDA 510(k) clearance K031952 for WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M, Substantially Equivalent on 2003-10-22. Applicant: Focus Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Focus Technologies, Inc.
Product code: Code NOP
Device class: Class 2
Regulation: 21 CFR 866.3940
Advisory panel: Microbiology
Date received: 2003-06-25
Decision date: 2003-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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