# K012741: Liquichek TDM Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Sep 12, 2001 after 27 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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 K893682 (1989). 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)
- K893682: Kit- Ciba Corning L-TDM I, II, Iii, Ciba Corning Diagnostics Corp. (1989) Summary page 1.

## Indications for use
Liquichek TDM 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/K012741
Methodology: https://510kreport.com/methodology