KQE — Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase Class II
FDA product code KQE covers "Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase", a Class II medical device regulated under 21 CFR 864.7360. 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
- KQE
- Device Class
- Class II
- Regulation Number
- 864.7360
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K823900 | alladin diagnostic | GLUCOSE-6-PHOSPHATE DEHYDROGENASE | February 7, 1983 |