K132237

Substantially Equivalent

PRODESSE PROFAST+ ASSAY

Applicant: Gen-Probe Prodesse, Inc.
Product code: OQW
Advisory panel: Microbiology
Date received: 2013-07-18
Decision date: 2013-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

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