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FDA 510(k)

PROFLU+ ASSAY

K-Number: K073029 · 2008-01-04

ApplicantProdesse, Inc.
Decision Date2008-01-04
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROFLU+ 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 2008-01-04 under 510(k) number K073029. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFLU+ ASSAY?

PROFLU+ ASSAY is a medical device that received FDA 510(k) clearance on 2008-01-04. The listed applicant is Prodesse, Inc.. The 510(k) number is K073029.

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

PROFLU+ ASSAY received FDA 510(k) clearance on 2008-01-04, under 510(k) number K073029.

Who is the listed applicant for PROFLU+ 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 PROFLU+ ASSAY?

The FDA product code for PROFLU+ ASSAY is OCC.

Related Clinical Trials

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.

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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.

K091053PROPARAFLU+ASSAYK092500MODIFICATION TO PROFLU+ ASSAYK090239PROGASTRO CD ASSAYK082688PRO HMPV+ ASSAYK081030MODIFICATION TO PROFLU+ ASSAY

Related Devices (Code: OCC)

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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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