i-STAT TBI Plasma cartridge with the i-STAT Alinity System— 510(k) K201778
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K201778 for i-STAT TBI Plasma cartridge with the i-STAT Alinity System, Substantially Equivalent on 2021-01-08. Applicant: Abbott Laboratories.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code QAT
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princton, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.