JLM — Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase Class II
FDA product code JLM covers "Isoenzymes, Electrophoretic, 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
- JLM
- 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 |
|---|---|---|---|
| K873625 | boots-celltech diagnostics | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) | October 20, 1987 |