510(k) K001118 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
| Applicant | DiaSorin, Inc., Ellicott City MD, US |
| Decision | Substantially Equivalent, Apr 25, 2000 |
| Received | Apr 7, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001118
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.