# K032017: Liquichek D-Dimer Control Level 1, 2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Aug 8, 2003 after 39 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K964716 (1997). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030182: Liquichek D-Dimer Control, Model 356, 357, Bio-Rad (2003) Summary page 2.

## Most influential descendants
- K050799: Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer Controls (2005), 4 descendants of its own
- K100716: Audit Microcv D-Dimer Linearity Set, Model K717M-5 (2011), 3 descendants of its own
- K152961: VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (2016), 2 descendants of its own
- K170864: VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (2017), 0 descendants of its own
- K162705: VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (2017), 0 descendants of its own

## Indications for use
Liquichek Ddimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for Ddimer.

Source page: https://510kreport.com/device/K032017
Methodology: https://510kreport.com/methodology