UROVYSION BLADDER CANCER RECURRENCE KIT— 510(k) K013785
Substantially EquivalentVysis
FDA 510(k) clearance K013785 for UROVYSION BLADDER CANCER RECURRENCE KIT, Substantially Equivalent on 2002-02-08. Applicant: Vysis. Device class: 2.
Clearance details
- Applicant
- Vysis
- Product code
- Code MMW
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Downers Grove, IL, US
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More clearances from Vysis
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