BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK— 510(k) K021646

Name: FDA 510(k) clearance K021646
Creator: U.S. Food and Drug Administration
Published: 2002-09-19

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K021646 for BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK, Substantially Equivalent on 2002-09-19. Applicant: Binax, Inc.. Device class: 2.

Clearance details

Applicant: Binax, Inc.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2002-05-20
Decision date: 2002-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

Download summary PDF View on FDA.gov ↗

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