Panels › Immunology › Product code DBE · Class 2
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation 866.5120
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DBE
| Company | 510(k)s | Recalls |
|---|---|---|
| Calbiochem-Behring Corp. | 1 | 0 |
| Clinical Sciences, Inc. | 1 | 0 |
| Immuno-Products Industries | 1 | 0 |
| Medica Corp. | 1 | 0 |
| Meloy Laboratories, Inc. | 1 | 0 |
| Zeus Scientific, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 1981 | K810983 | ANTISMOOTH MUSCLE ANTIBODY TEST SYS Immuno-Products Industries | DBE |
| Apr 24, 1980 | K800820 | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY Calbiochem-Behring Corp. | DBE |
| Feb 21, 1980 | K800228 | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT Clinical Sciences, Inc. | DBE |
| Apr 23, 1979 | K790430 | MEDICA II-F-ASMA TEST KIT Medica Corp. | DBE |
| Aug 4, 1977 | K771155 | ANTI-MITOCHONDRIAL Meloy Laboratories, Inc. | DBE |
| Jul 20, 1976 | K760156 | TEST, (IVDP) SMOOTHMUSCLE ANTIBODY Zeus Scientific, Inc. | DBE |
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