510(k) K944505 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
DIASTAT ENA SINGLE WELL SCREEN KIT
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Nov 21, 1994 |
| Received | Sep 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2005 | Diasorin Inc. Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay. Terminated |
LLL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.