DDE — Carbonic Anhydrase C, Antigen, Antiserum, Control Class I
FDA Device Classification
Classification Details
- Product Code
- DDE
- Device Class
- Class I
- Regulation Number
- 866.5200
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K902055 | diagnostic products | TENONE(TM) OPIATES CATALOG: VKSO1,4 | July 10, 1990 |
| K823680 | diagnostic products | COAT-A-COUNT MORPHINE KIT & COMPONENTS | January 5, 1983 |
| K820900 | syva | EMIT URINE METHADONE ASSAY #3E319 | April 26, 1982 |