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FDA 510(k)

PROGASTRO SSCS ASSAY

K-Number: K123274 · 2013-01-16

ApplicantGen-Probe Prodesse, Inc.
Decision Date2013-01-16
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROGASTRO SSCS 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 2013-01-16 under 510(k) number K123274. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGASTRO SSCS ASSAY?

PROGASTRO SSCS ASSAY is a medical device that received FDA 510(k) clearance on 2013-01-16. The listed applicant is Gen-Probe Prodesse, Inc.. The 510(k) number is K123274.

When did PROGASTRO SSCS ASSAY receive FDA 510(k) clearance?

PROGASTRO SSCS ASSAY received FDA 510(k) clearance on 2013-01-16, under 510(k) number K123274.

Who is the listed applicant for PROGASTRO SSCS 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 PROGASTRO SSCS ASSAY?

The FDA product code for PROGASTRO SSCS ASSAY is PCH.

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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.

K132238PROPARAFLU+ ASSAYK132237PRODESSE PROFAST+ ASSAYK132159PROADENO+ ASSAYK132200PRO HMPV+ ASSAYK132129PRODESSE PROFLU+ ASSAYK123838PRO HMPV+ ASSAY

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Related Devices (Code: PCH)

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K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex CorporationK254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251721Xpert GI PanelCepheidK252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.K251868Panther Fusion GI Bacterial AssayHologic

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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