# K990017: Abbott Immunoassay-MCC (Liquid) Control, Model Number 6E20-10

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jan 25, 1999 after 21 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Abbott Immunoassay-MCC (Liquid) 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/K990017
Methodology: https://510kreport.com/methodology