K231282
- 510(k) number
- K231282
- Device name
- LifeOutcomes C-Quest Blood Culture Sampling Device
- Applicant
- Lifeoutcomes, LLC CO · US
- Product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Colle
- Decision date
- 2024-01-26
- Date received
- 2023-05-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231282.pdf
Official FDA record: K231282
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.