DBE — Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DBE
- Device Class
- Class II
- Regulation Number
- 866.5120
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K810983 | immuno-products industries | ANTISMOOTH MUSCLE ANTIBODY TEST SYS | May 1, 1981 |
| K800820 | calbiochem-behring | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY | April 24, 1980 |
| K800228 | clinical sciences | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT | February 21, 1980 |
| K790430 | medica | MEDICA II-F-ASMA TEST KIT | April 23, 1979 |
| K771155 | meloy laboratories | ANTI-MITOCHONDRIAL | August 4, 1977 |
| K760156 | zeus scientific | TEST, (IVDP) SMOOTHMUSCLE ANTIBODY | July 20, 1976 |