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.. Device class: 2.
Clearance details
- Applicant
- Diesse Diagnostica Senese S.P.A.
- Product code
- Code LIP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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