3D-MSPECT— 510(k) K001026
Substantially EquivalentThe Reagents of the University of Michigan
FDA 510(k) clearance K001026 for 3D-MSPECT, Substantially Equivalent on 2000-06-20. Applicant: The Reagents of the University of Michigan. Device class: 2.
Clearance details
- Applicant
- The Reagents of the University of Michigan
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code KPS
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