510(k) K981580 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
HDL
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Jun 11, 1998 |
| Received | May 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981580
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2003 | Abbott Laboratories Diagnostic Div Aeroset Direct HDL Reagent, LN 7D67-01 Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.