510(k) K982708 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
SPQ TEST SYSTEM
| Applicant | DiaSorin, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Apr 2, 1999 |
| Received | Aug 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982708
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2005 | Diasorin Inc. Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent K Terminated |
DFC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.