Product code DET
- Device name
- Lactic Dehydrogenase, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 1
- Regulation number
- 866.5560
- Review panel
- IM
- 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 |
|---|---|---|---|
| K900107 | LD-1 | Boehringer Mannheim Corp. | 1990-01-18 |