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FDA 510(k)

TBI

K-Number: K232669 · 2023-09-29

ApplicantAbbott Laboratories
Decision Date2023-09-29
Product CodeQAT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TBI is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K232669. 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 TBI?

TBI is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Abbott Laboratories. The 510(k) number is K232669.

When did TBI receive FDA 510(k) clearance?

TBI received FDA 510(k) clearance on 2023-09-29, under 510(k) number K232669.

Who is the listed applicant for TBI?

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

What is the FDA product code for TBI?

The FDA product code for TBI is QAT.

Other records listing Abbott Laboratories as applicant

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Related Devices (Code: QAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240279VIDAS TBI (GFAP, UCH-L1)bioMerieux, Inc.K234143i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of CareK223602Traumatic brain injury (TBI) testAbbott LaboratoriesK201778i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories

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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