FDA 510(k)

EntericBio Dx Assay

K-Number: K182703 · 2019-06-19

Decision Date2019-06-19

Product CodePCH

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

EntericBio Dx Assay is a medical device manufactured by Serosep , Ltd.. It received FDA 510(k) clearance on 2019-06-19 under approval 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. It is manufactured by Serosep , Ltd.. The 510(k) number is K182703.

When was EntericBio Dx Assay approved by the FDA?

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

What company makes EntericBio Dx Assay?

EntericBio Dx Assay is manufactured by Serosep , Ltd..

What is the FDA product code for EntericBio Dx Assay?

The FDA product code for EntericBio Dx Assay is PCH.

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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.