REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
Device Facts
| Record ID | K931465 |
|---|---|
| Device Name | REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 |
| Applicant | Helena Laboratories |
| Product Code | JBD · Hematology |
| Decision Date | Jul 6, 1993 |
| 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.
