Cleared Traditional

SERAQUEST ANTI-THYROID PEROXIDASE (TPO)

K023593 · Quest Intl., Inc. · Immunology
Feb 2003
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K023593 is an FDA 510(k) clearance for the SERAQUEST ANTI-THYROID PEROXIDASE (TPO), a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on February 6, 2003, 104 days after receiving the submission on October 25, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K023593 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2002
Decision Date February 06, 2003
Days to Decision 104 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZO — System, Test, Thyroid Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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