SPIFE CHOLESTEROL PROFILE KIT— 510(k) K000603
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K000603 for SPIFE CHOLESTEROL PROFILE KIT, Substantially Equivalent on 2000-04-17. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- 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.