SPIFE A1AT kit— 510(k) K213396
Substantially EquivalentHelena Laboratories, Corp.
FDA 510(k) clearance K213396 for SPIFE A1AT kit, Substantially Equivalent on 2022-10-13. Applicant: Helena Laboratories, Corp..
Clearance details
- Applicant
- Helena Laboratories, Corp.
- Product code
- Code OBZ
- 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.