WEST NILE VIRUS IGM CAPTURE ELISA— 510(k) K040854

Name: FDA 510(k) clearance K040854
Creator: U.S. Food and Drug Administration
Published: 2004-06-30

Substantially Equivalent

Focus Technologies, Inc.

FDA 510(k) clearance K040854 for WEST NILE VIRUS IGM CAPTURE ELISA, Substantially Equivalent on 2004-06-30. 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: 2004-04-01
Decision date: 2004-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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