510(k) K951010 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
CHLAMYDIA OIA
| Applicant | Biostar, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Oct 7, 1995 |
| Received | Mar 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951010
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2003 | Thermo Biostar, Incorporated Chlamydia OIA. For in vitro diagnostic use, Terminated |
LJC | None listed |
| Mar 6, 2003 | Thermo Biostar, Incorporated Chlamydia OIA. For in vitro diagnostic use. Terminated |
LJC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.