K950414
Substantially EquivalentHEMAGEN ENA SM/RMP KIT (EIA METHOD)
- Applicant
- Hemagen Diagnostics, Inc.
- Product code
- LLL
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.