# K974826: BM Precipath (R) HDL/LDL-C Control

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 22, 1998 after 29 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Sigma Diagnostics Cardiolipid™ Controls: named in the summary without a submission number

## Indications for use
For the monitoring and control of processes for measuring the lipoproteins, HDL-C and LDL-C.

Source page: https://510kreport.com/device/K974826
Methodology: https://510kreport.com/methodology