510(k) K921183 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Jun 19, 1992 |
| Received | Mar 9, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921183
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.