I-STAT KAOLIN ACT TEST— 510(k) K023582
Substantially EquivalentI-Stat Corporation
FDA 510(k) clearance K023582 for I-STAT KAOLIN ACT TEST, Substantially Equivalent on 2003-09-08. Applicant: I-Stat Corporation.
Clearance details
- Applicant
- I-Stat Corporation
- 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.