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FDA 510(k)

VIDAS B.R.A.H.M.S. PCT ASSAY

K-Number: K071146 · 2007-10-11

ApplicantbioMerieux, Inc.
Decision Date2007-10-11
Product CodeNTM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS B.R.A.H.M.S. PCT ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2007-10-11 under 510(k) number K071146. The device is classified under product code NTM. 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 ASSAY?

VIDAS B.R.A.H.M.S. PCT ASSAY is a medical device that received FDA 510(k) clearance on 2007-10-11. The listed applicant is bioMerieux, Inc.. The 510(k) number is K071146.

When did VIDAS B.R.A.H.M.S. PCT ASSAY receive FDA 510(k) clearance?

VIDAS B.R.A.H.M.S. PCT ASSAY received FDA 510(k) clearance on 2007-10-11, under 510(k) number K071146.

Who is the listed applicant for VIDAS B.R.A.H.M.S. PCT ASSAY?

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

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

The FDA product code for VIDAS B.R.A.H.M.S. PCT ASSAY is NTM.

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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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