SPIFE LD-12 KIT, MODEL 3338— 510(k) K022455
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K022455 for SPIFE LD-12 KIT, MODEL 3338, Substantially Equivalent on 2002-10-01. 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.