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.. Device class: 2.

Clearance details

Applicant: Prodesse, Inc.
Product code: Code OOU
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2009-04-13
Decision date: 2009-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Prodesse, Inc.

K092500 — MODIFICATION TO PROFLU+ ASSAY2009-08-20
K090239 — PROGASTRO CD ASSAY2009-04-16
K082688 — PRO HMPV+ ASSAY2008-11-07
K081030 — MODIFICATION TO PROFLU+ ASSAY2008-05-02
K073029 — PROFLU+ ASSAY2008-01-04

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