510(k) K991726— BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI

Substantially Equivalent

Binax, Inc.

Clearance details

Applicant
Binax, Inc.
Product code
Code GTZ
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Portland, ME, US
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