FDA 510(k)

i-STAT TBI Cartridge with the i-STAT Alinity System

Numéro K : K234143 · 2024-03-27

Date de décision2024-03-27

Code produitQAT

Comité consultatifIM

DécisionSubstantially Equivalent

Résumé du dispositif

i-STAT TBI Cartridge with the i-STAT Alinity System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care. It received FDA 510(k) clearance on 2024-03-27 under 510(k) number K234143. The device is classified under product code QAT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the i-STAT TBI Cartridge with the i-STAT Alinity System?

i-STAT TBI Cartridge with the i-STAT Alinity System is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Abbott Point of Care. The 510(k) number is K234143.

When did i-STAT TBI Cartridge with the i-STAT Alinity System receive FDA 510(k) clearance?

i-STAT TBI Cartridge with the i-STAT Alinity System received FDA 510(k) clearance on 2024-03-27, under 510(k) number K234143.

Who is the listed applicant for i-STAT TBI Cartridge with the i-STAT Alinity System?

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

What is the FDA product code for i-STAT TBI Cartridge with the i-STAT Alinity System?

The FDA product code for i-STAT TBI Cartridge with the i-STAT Alinity System is QAT.

Essais cliniques associés

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Dispositifs connexes (Code : QAT)

K240279VIDAS TBI (GFAP, UCH-L1)bioMerieux, Inc.K232669TBIAbbott Laboratories K223602Traumatic brain injury (TBI) testAbbott Laboratories K201778i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories

Source officielle

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