# K990610: Abbott Tumor Marker-MCC (Lyophilized), Model 6E21-10

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Apr 27, 1999 after 62 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K011853: Abbott Tumormarker-MCC (Lyophilized), Levels 1 and 2, 2ML NO. 6E21-10 (2001), 0 descendants of its own

## Indications for use
Abbott Tumor Marker-MCC (Lyophilized) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

Source page: https://510kreport.com/device/K990610
Methodology: https://510kreport.com/methodology