K071474 is an FDA 510(k) clearance for the DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426. This device is classified as a Myeloperoxidase, Immunoassay, System, Test (Class II - Special Controls, product code NTV).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on December 10, 2008, 561 days after receiving the submission on May 29, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5600. 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..
| 510(k) Number | K071474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2007 |
| Decision Date | December 10, 2008 |
| Days to Decision | 561 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NTV — Myeloperoxidase, Immunoassay, System, Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5600 |
| Definition | 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. |