SERAQUEST ANTI-THYROID PEROXIDASE (TPO)— 510(k) K023593

Name: FDA 510(k) clearance K023593
Creator: U.S. Food and Drug Administration
Published: 2003-02-06

Substantially Equivalent

Quest Intl., Inc.

FDA 510(k) clearance K023593 for SERAQUEST ANTI-THYROID PEROXIDASE (TPO), Substantially Equivalent on 2003-02-06. Applicant: Quest Intl., Inc.. Device class: 2.

Clearance details

Applicant: Quest Intl., Inc.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 2002-10-25
Decision date: 2003-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Miami, FL, US

Download summary PDF View on FDA.gov ↗

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