ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
Device Facts
| Record ID | K000196 |
|---|---|
| Device Name | ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 |
| Applicant | Beckman Coulter, Inc. |
| Product Code | DDR · Immunology |
| Decision Date | Feb 18, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5680 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
