ENZY-WELL SYPHILIS IGG, MODEL 91106— 510(k) K050590
Substantially EquivalentDiesse Diagnostica Senese S.P.A.
FDA 510(k) clearance K050590 for ENZY-WELL SYPHILIS IGG, MODEL 91106, Substantially Equivalent on 2006-08-10. Applicant: Diesse Diagnostica Senese S.P.A..
Clearance details
- Applicant
- Diesse Diagnostica Senese S.P.A.
- Product code
- Code LIP
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.