# K000875: Assayed QCS 1,2, Cat. Nos. 970200, 970500

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Apr 20, 2000 after 31 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K131776: Aldolase Controls Level 2, and Aldolase Control Level 3 (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K000875
Methodology: https://510kreport.com/methodology