CARDIOMPO TEST
FDA 510(k) clearance K050029 · decided 2005-05-10
Clearance details
- K-number
- K050029
- Device name
- CARDIOMPO TEST
- Applicant
- Prognostix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-06
- Decision date
- 2005-05-10
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- NTV
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 (K071474) | Siemens Healthcare Diagnostics | 2008-12-10 |
Recalls involving this device
No recalls on record reference this clearance.