510(k) K042270— STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
Substantially EquivalentStat Chem, Inc.
Clearance details
- Applicant
- Stat Chem, Inc.
- Product code
- Code CEM
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orange, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.