MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST— 510(k) K010523

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K010523 for MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST, Substantially Equivalent on 2001-03-15. Applicant: Binax, Inc..

Clearance details

Applicant: Binax, Inc.
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 2001-02-22
Decision date: 2001-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Portland, ME, US

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