510(k) K071474
K071474 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426". The FDA issued a decision of Substantially Equivalent on December 10, 2008. The device falls under product code NTV (Myeloperoxidase, Immunoassay, System, Test), a Class II device regulated under 21 CFR 866.5600. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2008
- Date Received
- May 29, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Myeloperoxidase, Immunoassay, System, Test
- Device Class
- Class II
- Regulation Number
- 866.5600
- Review Panel
- TX
- Submission Type
MYELOPEROXIDASE, IMMUNOASSAY, SYSTEM, TEST IS INTENDED TO MEASURE MYELOPEROXIDASE IN HUMAN PLASMA, TO BE USED IN CONJUNCTION WITH CLINICAL HISTORY, ECG AND CARDIAC BIOMARKERS TO EVALUATE PATIENTS PRESENTING WITH CHEST PAIN THAT ARE AT RISK FOR MAJOR ADVERSE CARDIAC EVENTS, INCLUDING MYOCARDIAL INFARCTION, NEED FOR REVASCULARIZATION, OR DEATH.