PRO HMPV+ ASSAY— 510(k) K123838

Substantially Equivalent

Gen-Probe Prodesse, Inc.

FDA 510(k) clearance K123838 for PRO HMPV+ ASSAY, Substantially Equivalent on 2013-01-16. Applicant: Gen-Probe Prodesse, Inc.. Device class: 2.

Clearance details

Applicant: Gen-Probe Prodesse, Inc.
Product code: Code OEM
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2012-12-13
Decision date: 2013-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.