A,FDA2 LYOPHILIZED HEMO CONTROL
Device Facts
| Record ID | K800856 |
|---|---|
| Device Name | A,FDA2 LYOPHILIZED HEMO CONTROL |
| Applicant | Helena Laboratories |
| Product Code | JBD · Hematology |
| Decision Date | Apr 29, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7440 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.
