SPIFE URINE IFE— 510(k) K982639
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K982639 for SPIFE URINE IFE, Substantially Equivalent on 1998-11-04. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code DAO
- 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.