PROFAST+ ASSAY— 510(k) K101855

Substantially Equivalent

Gen-Probe Prodesse, Inc.

FDA 510(k) clearance K101855 for PROFAST+ ASSAY, Substantially Equivalent on 2010-07-23. Applicant: Gen-Probe Prodesse, Inc..

Clearance details

Applicant: Gen-Probe Prodesse, Inc.
Product code: Code OQW
Advisory panel: Microbiology
Date received: 2010-07-01
Decision date: 2010-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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