MLL — Hemoglobin C (Abnormal Hemoglobin Variant) Class II
FDA product code MLL covers "Hemoglobin C (Abnormal Hemoglobin Variant)", a Class II medical device regulated under 21 CFR 864.7415. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- MLL
- Device Class
- Class II
- Regulation Number
- 864.7415
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K923153 | isolab | HEMOCARD, HEMOGLOBIN C ASSAY | January 27, 1994 |