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FDA 510(k)

PROPARAFLU+ASSAY

K-Number: K091053 · 2009-11-20

ApplicantProdesse, Inc.
Decision Date2009-11-20
Product CodeOOU
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROPARAFLU+ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Prodesse, Inc.. It received FDA 510(k) clearance on 2009-11-20 under 510(k) number K091053. The device is classified under product code OOU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPARAFLU+ASSAY?

PROPARAFLU+ASSAY is a medical device that received FDA 510(k) clearance on 2009-11-20. The listed applicant is Prodesse, Inc.. The 510(k) number is K091053.

When did PROPARAFLU+ASSAY receive FDA 510(k) clearance?

PROPARAFLU+ASSAY received FDA 510(k) clearance on 2009-11-20, under 510(k) number K091053.

Who is the listed applicant for PROPARAFLU+ASSAY?

The FDA 510(k) record lists Prodesse, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROPARAFLU+ASSAY?

The FDA product code for PROPARAFLU+ASSAY is OOU.

Related Clinical Trials

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Other records listing Prodesse, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K092500MODIFICATION TO PROFLU+ ASSAYK090239PROGASTRO CD ASSAYK082688PRO HMPV+ ASSAYK081030MODIFICATION TO PROFLU+ ASSAYK073029PROFLU+ ASSAY

Related Devices (Code: OOU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172282Panther Fusion Paraflu AssayHologic, Inc.K132238PROPARAFLU+ ASSAYGen-Probe Prodesse, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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