510(k) K050029
K050029 is an FDA 510(k) premarket notification submitted by Prognostix, Inc. for the device "CARDIOMPO TEST". The FDA issued a decision of Substantially Equivalent on May 10, 2005. The device falls under product code NTV (Myeloperoxidase, Immunoassay, System, Test), a Class II device regulated under 21 CFR 866.5600.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2005
- Date Received
- January 6, 2005
- 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.