PROGASTRO CD ASSAY— 510(k) K090239

Substantially Equivalent

Prodesse, Inc.

FDA 510(k) clearance K090239 for PROGASTRO CD ASSAY, Substantially Equivalent on 2009-04-16. Applicant: Prodesse, Inc.. Device class: 1.

Clearance details

Applicant: Prodesse, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2009-02-02
Decision date: 2009-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
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.