510(k) K071474
- Device
- DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS
- 510(k) number
- K071474
- Product code
- NTV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-12-10
- Date received
- 2007-05-29
- Regulation
- 866.5600
- Classification name
- Myeloperoxidase, Immunoassay, System, Test
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE M PLUMMER
- Address
- Ms 514, P.O. Box 6101 Newark DE US 19714 19714
FDA Registration Numbers#
- 2032839
Source Documents#
Other 510(k) Records For Product Code NTV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050029 | CARDIOMPO TEST | Prognostix, Inc. | 2005-05-10 |
Legacy Summary#
summary
FDA Review#
Decision Summary