K022757
Substantially EquivalentSPIFE CK KIT, MODEL 3332, 3333
- Applicant
- Helena Laboratories
- Product code
- JHY
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.