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FDA 510(k)

BD MAX CT/GC/TV 20-Day QC Panel

K-Number: K181683 · 2018-08-28

ApplicantMicrobiologics, Inc.
Decision Date2018-08-28
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX CT/GC/TV 20-Day QC Panel is a medical device manufactured by Microbiologics, Inc.. It received FDA 510(k) clearance on 2018-08-28 under approval number K181683. 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 CT/GC/TV 20-Day QC Panel?

BD MAX CT/GC/TV 20-Day QC Panel is a medical device that received FDA 510(k) clearance on 2018-08-28. It is manufactured by Microbiologics, Inc.. The 510(k) number is K181683.

When was BD MAX CT/GC/TV 20-Day QC Panel approved by the FDA?

BD MAX CT/GC/TV 20-Day QC Panel received FDA 510(k) clearance on 2018-08-28, under approval number K181683.

What company makes BD MAX CT/GC/TV 20-Day QC Panel?

BD MAX CT/GC/TV 20-Day QC Panel is manufactured by Microbiologics, Inc..

What is the FDA product code for BD MAX CT/GC/TV 20-Day QC Panel?

The FDA product code for BD MAX CT/GC/TV 20-Day QC Panel is PMN.

Other Devices by Microbiologics, Inc.

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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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