510(k) K231282

LifeOutcomes C-Quest™ Blood Culture Sampling Device by Lifeoutcomes, LLC — Product Code JKA

K231282 is an FDA 510(k) premarket notification submitted by Lifeoutcomes, LLC for the device "LifeOutcomes C-Quest™ Blood Culture Sampling Device". The FDA issued a decision of Substantially Equivalent on January 26, 2024. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675.