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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K231282
Device Name LifeOutcomes C-Quest™ Blood Culture Sampling Device
Applicant
Lifeoutcomes, LLC
88 Inverness Circle E., Unit E-102
Englewood,  CO  80112
Applicant Contact Robert J. McKinnon
Correspondent
Speed TO Market, Inc.
P.O. Box 3018
Nederland,  CO  80466
Correspondent Contact Thomas Kroenke
Regulation Number862.1675
Classification Product Code
JKA  
Date Received05/03/2023
Decision Date 01/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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