FDA 510(k)

LifeOutcomes C-Quest™ Blood Culture Sampling Device

Numéro K : K231282 · 2024-01-26

Date de décision2024-01-26

Code produitJKA

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

LifeOutcomes C-Quest™ Blood Culture Sampling Device is the device name listed in this FDA 510(k) record. The listed applicant is Lifeoutcomes, LLC. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K231282. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the LifeOutcomes C-Quest™ Blood Culture Sampling Device?

LifeOutcomes C-Quest™ Blood Culture Sampling Device is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Lifeoutcomes, LLC. The 510(k) number is K231282.

When did LifeOutcomes C-Quest™ Blood Culture Sampling Device receive FDA 510(k) clearance?

LifeOutcomes C-Quest™ Blood Culture Sampling Device received FDA 510(k) clearance on 2024-01-26, under 510(k) number K231282.

Who is the listed applicant for LifeOutcomes C-Quest™ Blood Culture Sampling Device?

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

What is the FDA product code for LifeOutcomes C-Quest™ Blood Culture Sampling Device?

The FDA product code for LifeOutcomes C-Quest™ Blood Culture Sampling Device is JKA.

Essais cliniques associés

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Dispositifs connexes (Code : JKA)

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Source officielle

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