# K134013: Lyphochek Allergen Sige  Control, Negative, Lypochek Allergen Sige Control, Negative Minipak, Lyphochek Allergen Sige CO

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Apr 24, 2014 after 115 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
Longest line of descent: 1 generation back to K832218 (1983). 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)
- K832218: Allergen Control Inhalent, Ventrex Laboratories, Inc. (1983) Summary page 1.

## Indications for use
Lyphochek Allergen sIgE Control Is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package Insert.

Source page: https://510kreport.com/device/K134013
Methodology: https://510kreport.com/methodology