K010617
Substantially EquivalentSPIFE IFE CALIBRATOR AND CONTROL KIT
- Applicant
- Helena Laboratories
- Product code
- DEW
- Advisory panel
- Immunology
- 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.