BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065— 510(k) K032166

Name: FDA 510(k) clearance K032166
Creator: U.S. Food and Drug Administration
Published: 2003-10-21

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K032166 for BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065, Substantially Equivalent on 2003-10-21. Applicant: Binax, Inc.. Device class: 1.

Clearance details

Applicant: Binax, Inc.
Product code: Code GQG
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 2003-07-16
Decision date: 2003-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

Download summary PDF View on FDA.gov ↗

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