FDA 510(k)

VIDAS B.R.A.H.M.S. PCT (PCT)

K-Number: K160911 · 2016-06-28

Decision Date2016-06-28

Product CodePMT

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

VIDAS B.R.A.H.M.S. PCT (PCT) is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2016-06-28 under approval number K160911. The device is classified under product code PMT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS B.R.A.H.M.S. PCT (PCT)?

VIDAS B.R.A.H.M.S. PCT (PCT) is a medical device that received FDA 510(k) clearance on 2016-06-28. It is manufactured by bioMerieux, Inc.. The 510(k) number is K160911.

When was VIDAS B.R.A.H.M.S. PCT (PCT) approved by the FDA?

VIDAS B.R.A.H.M.S. PCT (PCT) received FDA 510(k) clearance on 2016-06-28, under approval number K160911.

What company makes VIDAS B.R.A.H.M.S. PCT (PCT)?

VIDAS B.R.A.H.M.S. PCT (PCT) is manufactured by bioMerieux, Inc..

What is the FDA product code for VIDAS B.R.A.H.M.S. PCT (PCT)?

The FDA product code for VIDAS B.R.A.H.M.S. PCT (PCT) is PMT.

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Related Devices (Code: PMT)

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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.