510(k) K982341 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
DIRECT HDL-CHOLESTROL LIQUID
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, GB |
| Decision | Substantially Equivalent, Jul 30, 1998 |
| Received | Jun 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982341
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL) Terminated |
LBS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.