
Lifeoutcomes, LLC
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LifeOutcomes C-Quest Blood Culture Sampling Device is an FDA 510(k)-cleared medical device (K231282) manufactured by Lifeoutcomes, LLC. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 2024. Regulation: 8.