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FDA 510(k)

BD MAX Enteric Parasite Panel

K-Number: K220193 · 2022-08-19

ApplicantBecton, Dickinson and Company
Decision Date2022-08-19
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX Enteric Parasite Panel is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K220193. 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 BD MAX Enteric Parasite Panel?

BD MAX Enteric Parasite Panel is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K220193.

When did BD MAX Enteric Parasite Panel receive FDA 510(k) clearance?

BD MAX Enteric Parasite Panel received FDA 510(k) clearance on 2022-08-19, under 510(k) number K220193.

Who is the listed applicant for BD MAX Enteric Parasite Panel?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD MAX Enteric Parasite Panel?

The FDA product code for BD MAX Enteric Parasite Panel is PCH.

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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.

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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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