PROPARAFLU+ASSAY— 510(k) K091053

Substantially Equivalent

Prodesse, Inc.

FDA 510(k) clearance K091053 for PROPARAFLU+ASSAY, Substantially Equivalent on 2009-11-20. Applicant: Prodesse, Inc..

Clearance details

Applicant: Prodesse, Inc.
Product code: Code OOU
Advisory panel: Microbiology
Date received: 2009-04-13
Decision date: 2009-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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