LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
Device Facts
| Record ID | K911347 |
|---|---|
| Device Name | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL |
| Applicant | Bio-Rad |
| Product Code | JCM · Hematology |
| Decision Date | Jun 10, 1991 |
| 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.
