HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
Device Facts
| Record ID | K011389 |
|---|---|
| Device Name | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) |
| Applicant | Canterbury Health Laboratories |
| Product Code | JCM · Hematology |
| Decision Date | Jun 21, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7415 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.
Special Controls
*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
