i-STAT Hematocrit test with i-STAT Alinity System— 510(k) K163342
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K163342 for i-STAT Hematocrit test with i-STAT Alinity System, Substantially Equivalent on 2017-08-22. Applicant: Abbott Laboratories.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code JPI
- Advisory panel
- Hematology
- 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.