510(k) K970220 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
IS-ANTI-SM TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Apr 8, 1997 |
| Received | Jan 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970220
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2012 | Diamedix Corporation The Is-anti-Sm test kits****Catalog No: 720-240***
Product Usage:
The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm ant Terminated |
LLL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.