MODIFICATION TO SERAQUEST EB VCA IGG— 510(k) K033915

Name: FDA 510(k) clearance K033915
Creator: U.S. Food and Drug Administration
Published: 2004-01-16

Substantially Equivalent

Quest Intl., Inc.

FDA 510(k) clearance K033915 for MODIFICATION TO SERAQUEST EB VCA IGG, Substantially Equivalent on 2004-01-16. Applicant: Quest Intl., Inc.. Device class: 1.

Clearance details

Applicant: Quest Intl., Inc.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 2003-12-18
Decision date: 2004-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: North Miami, FL, US

Download summary PDF View on FDA.gov ↗

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