JBE · Cell Enzymes (Erythrocytic And Leukocytic)
Hematology · 21 CFR 864.7100 · Class 2
Overview
| Product Code | JBE |
|---|---|
| Device Name | Cell Enzymes (Erythrocytic And Leukocytic) |
| Regulation | 21 CFR 864.7100 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K822733 | SIGMA REAGENT SYSTEM NO. 885 | Sigma Chemical Co. | Dec 3, 1982 | SESE |
Top Applicants
- Sigma Chemical Co. — 1 clearance
