SERAQUEST ANTI-DSDNA— 510(k) K980391

Substantially Equivalent

Quest Intl., Inc.

FDA 510(k) clearance K980391 for SERAQUEST ANTI-DSDNA, Substantially Equivalent on 1998-04-24. Applicant: Quest Intl., Inc.. Device class: 2.

Clearance details

Applicant: Quest Intl., Inc.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1998-02-02
Decision date: 1998-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Miami, FL, US

Download summary PDF View on FDA.gov ↗

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