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FDA 510(k)

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel

K-Number: K181711 · 2018-08-15

ApplicantMicrobiologics, Inc.
Decision Date2018-08-15
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel is the device name listed in this FDA 510(k) record. The listed applicant is Microbiologics, Inc.. It received FDA 510(k) clearance on 2018-08-15 under 510(k) number K181711. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel?

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Microbiologics, Inc.. The 510(k) number is K181711.

When did BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel receive FDA 510(k) clearance?

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181711.

Who is the listed applicant for BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel?

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

What is the FDA product code for BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel?

The FDA product code for BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel is PMN.

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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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