BinaxNOW G6PD Test— 510(k) K161364

Substantially Equivalent

Alere Scarborough, Inc.

FDA 510(k) clearance K161364 for BinaxNOW G6PD Test, Substantially Equivalent on 2016-06-17. Applicant: Alere Scarborough, Inc..

Clearance details

Applicant: Alere Scarborough, Inc.
Product code: Code JBF
Advisory panel: Hematology
Date received: 2016-05-17
Decision date: 2016-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, US

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