BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST— 510(k) K012521

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K012521 for BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST, Substantially Equivalent on 2001-11-30. Applicant: Binax, Inc..

Clearance details

Applicant: Binax, Inc.
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 2001-08-06
Decision date: 2001-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

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