SPECTRAL WEST NILE VIRUS IGM STATUS TEST— 510(k) K052519

Substantially Equivalent

Spectral Diagnostics, Inc.

FDA 510(k) clearance K052519 for SPECTRAL WEST NILE VIRUS IGM STATUS TEST, Substantially Equivalent on 2006-11-30. Applicant: Spectral Diagnostics, Inc..

Clearance details

Applicant: Spectral Diagnostics, Inc.
Product code: Code NOP
Advisory panel: Microbiology
Date received: 2005-09-14
Decision date: 2006-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

Download summary PDF View on FDA.gov ↗

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