# K980982: Avocet System Liquid Control Level 1 and Level 2

- Pathway: 510(k) (Traditional)
- Applicant: Avocet Medical, Inc.
- Decided: Apr 16, 1998 after 30 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
This product (The Avocetpr System Liquid Controls, Level 1 and Level 2) is used with the Avocetpr in vitro diagnostic system to validate system performance. It is intended for use by health care professionals in assessing the functionality of the Avocetpr System when monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.

Source page: https://510kreport.com/device/K980982
Methodology: https://510kreport.com/methodology