510(k) K992571— I-STAT SYSTEM
Substantially EquivalentI-Stat Corp.
Clearance details
- Applicant
- I-Stat Corp.
- Product code
- Code JBP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Windsor, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.