510(k) K183680— i-STAT CHEM8+ cartridge with the i-STAT 1 System
Substantially EquivalentAbbott Point of Care, Inc.
Clearance details
- Applicant
- Abbott Point of Care, Inc.
- 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.