BINAX PROLACTIN IRMA DIAGNOSTIC KIT— 510(k) K880218

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K880218 for BINAX PROLACTIN IRMA DIAGNOSTIC KIT, Substantially Equivalent on 1988-03-01. Applicant: Binax, Inc..

Clearance details

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