K013466
Substantially EquivalentSPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
- Applicant
- Helena Laboratories
- Product code
- JHO
- 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.