BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT— 510(k) K912748

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K912748 for BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT, Substantially Equivalent on 1991-10-31. Applicant: Binax, Inc..

Clearance details

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