STANDARD IMAGING IVB 1000 WELL CHAMBER— 510(k) K013548
Substantially EquivalentStandard Imaging, Inc.
FDA 510(k) clearance K013548 for STANDARD IMAGING IVB 1000 WELL CHAMBER, Substantially Equivalent on 2001-11-09. Applicant: Standard Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Standard Imaging, Inc.
- Product code
- Code KPT
- Device class
- Class 2
- Regulation
- 21 CFR 892.1360
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Middleton, WI, US
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