FDA Product Code
FDA Product Code NTV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5600
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071474 | DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 | Siemens Healthcare Diagnostics | 2008-12-10 | Traditional | PDF ↗ |
| K050029 | CARDIOMPO TEST | Prognostix, Inc. | 2005-05-10 | Traditional | PDF ↗ |
Product code NTV · Class II · Immunology. Data: openFDA.