# K971190: N-Geneous HDL Cholesterol Kit/Cholesterol Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Jun 16, 1997 after 77 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962186 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962186: N-Geneous HDL Cholesterol Kit/Cholesterol Calibrator, Genzyme Corp. (1996) Summary page 1.
- (no number) Sodium Phosphotungstate MgCl₂ method: named in the summary without a submission number

## Indications for use
For the quantitative determination of high density lipoprotein (HDL) cholesterol in human serum or plasma. For the calibration of N-geneous HDL Cholesterol assay in serum or plasma.

Source page: https://510kreport.com/device/K971190
Methodology: https://510kreport.com/methodology