DBE
6 FDA 510(k) clearances · Product code
18 daysmedian time to decision
52 days90th percentile
6clearances measured
FDA profile
- Official device name
- Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5120
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ANTISMOOTH MUSCLE ANTIBODY TEST SYS (K810983) | Immuno-Products Industries | 1981-05-01 |
| AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY (K800820) | Calbiochem-Behring Corp. | 1980-04-24 |
| IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT (K800228) | Clinical Sciences, Inc. | 1980-02-21 |
| MEDICA II-F-ASMA TEST KIT (K790430) | Medica Corp. | 1979-04-23 |
| ANTI-MITOCHONDRIAL (K771155) | Meloy Laboratories, Inc. | 1977-08-04 |
| TEST, (IVDP) SMOOTHMUSCLE ANTIBODY (K760156) | Zeus Scientific, Inc. | 1976-07-20 |
Track DBE automatically
Every clearance here is in the API, with alerts when new ones post.