ProParaFlu+ Assay— 510(k) K153223

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K153223 for ProParaFlu+ Assay, Substantially Equivalent on 2015-12-09. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code OOU
Advisory panel: Microbiology
Date received: 2015-11-06
Decision date: 2015-12-09
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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