Product code DDE
- Device name
- Carbonic Anhydrase C, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 1
- Regulation number
- 866.5200
- Review panel
- HE
- 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 |
|---|
| K902055 | TENONE(TM) OPIATES CATALOG: VKSO1,4 | Diagnostic Products Corp. | 1990-07-10 |
| K823680 | COAT-A-COUNT MORPHINE KIT & COMPONENTS | Diagnostic Products Corp. | 1983-01-05 |
| K820900 | EMIT URINE METHADONE ASSAY #3E319 | Syva Co. | 1982-04-26 |