BINAXNOW G6PD TEST— 510(k) K080003

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K080003 for BINAXNOW G6PD TEST, Substantially Equivalent on 2008-10-23. Applicant: Binax, Inc.. Device class: 2.

Clearance details

Applicant: Binax, Inc.
Product code: Code JBF
Device class: Class 2
Regulation: 21 CFR 864.7360
Advisory panel: Hematology
Date received: 2008-01-02
Decision date: 2008-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, 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.