REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
Device Facts
| Record ID | K901143 |
|---|---|
| Device Name | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) |
| Applicant | Helena Laboratories |
| Product Code | JBD · Hematology |
| Decision Date | May 23, 1990 |
| 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.
