ACCESS FOLATE ASSAY (MODIFICATION)
Device Facts
| Record ID | K955434 |
|---|---|
| Device Name | ACCESS FOLATE ASSAY (MODIFICATION) |
| Applicant | Beckman Coulter, Inc. |
| Product Code | CGN · Clinical Chemistry |
| Decision Date | Jan 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1295 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.
