FDA Product Code
FDA Product Code DBE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5120
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K810983 | ANTISMOOTH MUSCLE ANTIBODY TEST SYS | Immuno-Products Industries | 1981-05-01 | Traditional | PDF ↗ |
| K800820 | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY | Calbiochem-Behring Corp. | 1980-04-24 | Traditional | PDF ↗ |
| K800228 | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT | Clinical Sciences, Inc. | 1980-02-21 | Traditional | PDF ↗ |
| K790430 | MEDICA II-F-ASMA TEST KIT | Medica Corp. | 1979-04-23 | Traditional | PDF ↗ |
| K771155 | ANTI-MITOCHONDRIAL | Meloy Laboratories, Inc. | 1977-08-04 | Traditional | PDF ↗ |
| K760156 | TEST, (IVDP) SMOOTHMUSCLE ANTIBODY | Zeus Scientific, Inc. | 1976-07-20 | Traditional | PDF ↗ |
Product code DBE · Class II · Immunology. Data: openFDA.