K061069
Substantially EquivalentSPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
- Applicant
- Helena Laboratories
- Product code
- CFF
- 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.