LifeOutcomes C-Quest Blood Culture Sampling Device
Lifeoutcomes, LLC · Clinical Chemistry
Open FDA's page for this record- Third party flag
- N
- City
- Englewood
- Advisory committee description
- Clinical Chemistry
- Address 1
- 88 Inverness Cir. E., Unit E-102
- Statement or summary
- Summary
- Product code
- JKA
- Zip code
- 80112
- Applicant
- Lifeoutcomes, LLC
- Decision date
- 2024-01-26
- Decision code
- SESE
- Country code
- US
- Device name
- LifeOutcomes C-Quest Blood Culture Sampling Device
- Advisory committee
- CH
- Contact
- Robert J. McKinnon
- K number
- K231282
- State
- CO
- Date received
- 2023-05-03
- Review advisory committee
- HO
- Postal code
- 80112
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1675
- Device class
- 2
- Registration number
- 3008496607, 3030243919, 1055927, 2648045, 3017509841, 3030446844, 3000268902, 3020294761, 3013298431, 3015058854, 3019807891, 1058602, 3026940910, 3030626857, 3037918935, 1917413, 3008337059, 1055236, 3024537844, 3009518015, 3006425876, 9616567, 3005674478, 3013696225, 3009742443, 3016661372, 3042871620, 3043226252, 3003974574, 3033589330, 3005910889, 9681835, 3013652330, 3044026004, 3001124136, 3019004087, 9680794, 8010026, 3014662855, 3035708936 +180 more
- FEI number
- 3008496607, 3030243919, 2648045, 3017509841, 3030446844, 3000268902, 3020294761, 3013298431, 2828, 1000113359, 3003282181, 3015058854, 3019807891, 3000974732, 3026940910, 3030626857, 3037918935, 1000208624, 1917413, 3008337059, 3024537844, 3009518015, 3006425876, 3005674478, 3013696225, 3009742443, 3016661372, 3042871620, 3043226252, 3003974574, 3033589330, 3005910889, 3000206435, 3013652330, 3044026004, 3002808075, 3001236905, 2649711, 3001124136, 3019004087 +180 more