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FDA 510(k)

PROPARAFLU+ ASSAY

K-Number: K132238 · 2013-08-26

ApplicantGen-Probe Prodesse, Inc.
Decision Date2013-08-26
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 Gen-Probe Prodesse, Inc.. It received FDA 510(k) clearance on 2013-08-26 under 510(k) number K132238. 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 2013-08-26. The listed applicant is Gen-Probe Prodesse, Inc.. The 510(k) number is K132238.

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

PROPARAFLU+ ASSAY received FDA 510(k) clearance on 2013-08-26, under 510(k) number K132238.

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

The FDA product code for PROPARAFLU+ ASSAY is OOU.

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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.

K132237PRODESSE PROFAST+ ASSAYK132159PROADENO+ ASSAYK132200PRO HMPV+ ASSAYK132129PRODESSE PROFLU+ ASSAYK123274PROGASTRO SSCS ASSAYK123838PRO HMPV+ ASSAY

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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.K091053PROPARAFLU+ASSAYProdesse, Inc.

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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