LKZ · Red-Cell Count By Photometry
Hematology · 21 CFR 864.7100 · Class 2
Overview
| Product Code | LKZ |
|---|---|
| Device Name | Red-Cell Count By Photometry |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833708 | COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE | Worthington Diagnostic Systems | Jan 4, 1984 | SESE |
| K832771 | ERYTHROCYTE TEST | Bio-Analytics Laboratories, Inc. | Oct 28, 1983 | SESE |
Top Applicants
- Bio-Analytics Laboratories, Inc. — 1 clearance
- Worthington Diagnostic Systems — 1 clearance
