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FDA 510(k)

EntericBio Dx Assay

K-Number: K182703 · 2019-06-19

ApplicantSerosep , Ltd.
Decision Date2019-06-19
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EntericBio Dx Assay is the device name listed in this FDA 510(k) record. The listed applicant is Serosep , Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K182703. 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 EntericBio Dx Assay?

EntericBio Dx Assay is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Serosep , Ltd.. The 510(k) number is K182703.

When did EntericBio Dx Assay receive FDA 510(k) clearance?

EntericBio Dx Assay received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182703.

Who is the listed applicant for EntericBio Dx Assay?

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

What is the FDA product code for EntericBio Dx Assay?

The FDA product code for EntericBio Dx Assay is PCH.

Related Devices (Code: PCH)

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.

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

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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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