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FDA 510(k)

PRODESSE PROFLU+ ASSAY

K-Number: K132129 · 2013-08-09

ApplicantGen-Probe Prodesse, Inc.
Decision Date2013-08-09
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PRODESSE PROFLU+ ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe Prodesse, Inc.. It received FDA 510(k) clearance on 2013-08-09 under 510(k) number K132129. 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 PRODESSE PROFLU+ ASSAY?

PRODESSE PROFLU+ ASSAY is a medical device that received FDA 510(k) clearance on 2013-08-09. The listed applicant is Gen-Probe Prodesse, Inc.. The 510(k) number is K132129.

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

PRODESSE PROFLU+ ASSAY received FDA 510(k) clearance on 2013-08-09, under 510(k) number K132129.

Who is the listed applicant for PRODESSE PROFLU+ ASSAY?

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

What is the FDA product code for PRODESSE PROFLU+ ASSAY?

The FDA product code for PRODESSE PROFLU+ ASSAY is OCC.

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Other records listing Gen-Probe 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.

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Official Source

View on FDA Database →

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

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