Panels › Immunology › Product code DBM · Class 2
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation 866.5090
0510(k)s in 12 months (27 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in DBM
| Company | 510(k)s | Recalls |
|---|---|---|
| Elias U.S.A., Inc. | 2 | 0 |
| Inova Diagnostics, Inc. | 2 | 0 |
| Zeus Scientific, Inc. | 2 | 0 |
| The Binding Site, Ltd. | 1 | 0 |
| Bio-Rad Laboratories | 0 | 1 |
| Bioware Products | 1 | 0 |
| Calbiochem | 1 | 0 |
| Calbiochem-Behring Corp. | 1 | 0 |
| Clinical Sciences, Inc. | 1 | 0 |
| David A. Fuccillo, Ph.D. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2008 | Bio-Rad Laboratories Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, Terminated |
DBM | K810863 |
| Apr 6, 2005 | Diasorin Inc. Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit Terminated |
DBM | K921183 |
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