510(k) K041928 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
| Applicant | Diagnostic Chemicals , Ltd., Charlottetown, P.E., CA |
| Decision | Substantially Equivalent, Nov 23, 2004 |
| Received | Jul 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041928
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.