QUICKLAB RSV— 510(k) K021789

Substantially Equivalent

Integrated Biotechnology Corp.

FDA 510(k) clearance K021789 for QUICKLAB RSV, Substantially Equivalent on 2002-11-20. Applicant: Integrated Biotechnology Corp.. Device class: 1.

Clearance details

Applicant: Integrated Biotechnology Corp.
Product code: Code GQG
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 2002-05-31
Decision date: 2002-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, 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.