DISTAT ANTI-DSDNA KIT— 510(k) K905386
Substantially EquivalentShield Diagnostics, Ltd.
FDA 510(k) clearance K905386 for DISTAT ANTI-DSDNA KIT, Substantially Equivalent on 1990-12-13. Applicant: Shield Diagnostics, Ltd.. Device class: 2.
Clearance details
- Applicant
- Shield Diagnostics, Ltd.
- Product code
- Code KTL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, GB
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