Product code JKG
- Device name
- L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1420
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K770519 | REAGENT SYSTEM 153-UV | Sigma Chemical Co. | 1977-06-03 |