SERAQUEST ANTI-SM/RNP— 510(k) K980811

Substantially Equivalent

Quest Intl., Inc.

FDA 510(k) clearance K980811 for SERAQUEST ANTI-SM/RNP, Substantially Equivalent on 1998-05-12. Applicant: Quest Intl., Inc.. Device class: 2.

Clearance details

Applicant: Quest Intl., Inc.
Product code: Code LKP
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1998-03-03
Decision date: 1998-05-12
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.