The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge, Calibrator,control, Model Rf425, Rc425,rc426.
| Device ID | K071474 |
| 510k Number | K071474 |
| Device Name: | DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 |
| Classification | Myeloperoxidase, Immunoassay, System, Test |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | George M Plummer |
| Correspondent | George M Plummer SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | NTV |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-29 |
| Decision Date | 2008-12-10 |
| Summary: | summary |