# K812574: HDL Cholesterol Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Sep 24, 1981 after 15 days
- Product code: LBR (Ldl & Vldl Precipitation, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 10, 2009 · Not classified · Z-0859-2010: The firm initiated the recall due to the presence of visible contamination of the product.
- Nov 10, 2009 · Not classified · Z-0860-2010: The firm initiated the recall due to the presence of visible contamination of the product.

Source page: https://510kreport.com/device/K812574
Methodology: https://510kreport.com/methodology