CER — 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase Class II
FDA product code CER covers "2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase", a Class II medical device regulated under 21 CFR 862.1440. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- CER
- Device Class
- Class II
- Regulation Number
- 862.1440
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K792416 | volu sol medical industries | ELVI TOTAL PROTEINS | December 7, 1979 |