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FDA 510(k)

VIDAS TBI (GFAP, UCH-L1)

K-Number: K240279 · 2024-05-01

ApplicantbioMerieux, Inc.
Decision Date2024-05-01
Product CodeQAT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VIDAS TBI (GFAP, UCH-L1) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2024-05-01 under 510(k) number K240279. The device is classified under product code QAT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS TBI (GFAP, UCH-L1)?

VIDAS TBI (GFAP, UCH-L1) is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is bioMerieux, Inc.. The 510(k) number is K240279.

When did VIDAS TBI (GFAP, UCH-L1) receive FDA 510(k) clearance?

VIDAS TBI (GFAP, UCH-L1) received FDA 510(k) clearance on 2024-05-01, under 510(k) number K240279.

Who is the listed applicant for VIDAS TBI (GFAP, UCH-L1)?

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 TBI (GFAP, UCH-L1)?

The FDA product code for VIDAS TBI (GFAP, UCH-L1) is QAT.

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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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