510(k) K812574 ยท LBR Ldl & Vldl Precipitation, Hdl
HDL CHOLESTEROL REAGENT
| Applicant | Pointe Scientific, Inc.,, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 24, 1981 |
| Received | Sep 9, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812574
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2010 | Pointe Scientific, Inc. Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Terminated |
LBR | None listed |
| Feb 25, 2010 | Pointe Scientific, Inc. Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry).
For the quantitative determination of high density lipopr Terminated |
LBR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.