CARDIOMPO TEST— 510(k) K050029
Substantially EquivalentPrognostix, Inc.
FDA 510(k) clearance K050029 for CARDIOMPO TEST, Substantially Equivalent on 2005-05-10. Applicant: Prognostix, Inc.. Device class: 2.
Clearance details
- Applicant
- Prognostix, Inc.
- Product code
- Code NTV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5600
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code NTV
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