JKH — Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen Class I
FDA product code JKH covers "Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen", a Class I medical device regulated under 21 CFR 862.1420. 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
- JKH
- Device Class
- Class I
- Regulation Number
- 862.1420
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K770902 | sigma chemical | COLORIMETRIC DETERM. SOCITRATE DEHYDRO. | July 14, 1977 |