VARIANT SICKLE CELL SHORT PROGRAM
Device Facts
| Record ID | K924813 |
|---|---|
| Device Name | VARIANT SICKLE CELL SHORT PROGRAM |
| Applicant | Bio-Rad |
| Product Code | GKA · Hematology |
| Decision Date | Jan 14, 1993 |
| 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.
