DeviceClearance

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010— 510(k) K083744

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K083744 for BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010, Substantially Equivalent on 2009-09-01. Applicant: Binax, Inc..

Clearance details

Applicant
Binax, Inc.
Product code
Code MJZ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Scarborough, ME, US
Download summary PDFView on FDA.gov ↗

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