# K971952: Lyphochek Hypertension Markers Control (Cat. NO. 600)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 16, 1997 after 19 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) Renin Control: named in the summary without a submission number

## Indications for use
Lyphochek Hypertension Markers Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K971952
Methodology: https://510kreport.com/methodology