SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452— 510(k) K020467
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K020467 for SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452, Substantially Equivalent on 2002-03-29. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CFE
- 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.