# K011853: Abbott Tumormarker-MCC (Lyophilized), Levels 1 and 2, 2ML NO. 6E21-10

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jul 17, 2001 after 34 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 K990610 (1999). 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)
- K990610: Abbott Tumor Marker-MCC (Lyophilized), Model 6E21-10, Bio-Rad (1999) Summary page 1.

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

Source page: https://510kreport.com/device/K011853
Methodology: https://510kreport.com/methodology