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 East, 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 Number | 862.1675
|
Classification Product Code |
|
Date Received | 05/03/2023 |
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
|
|
|