BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK— 510(k) K021687

Name: FDA 510(k) clearance K021687
Creator: U.S. Food and Drug Administration
Published: 2002-09-13

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K021687 for BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK, Substantially Equivalent on 2002-09-13. 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: 2002-05-22
Decision date: 2002-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

Download summary PDF View on FDA.gov ↗

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