# K963111: Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S

- Pathway: 510(k) (Traditional)
- Applicant: Chromogenix AB
- Decided: Dec 23, 1996 after 133 days
- Product code: GGW (Test, Time, Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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 K945940 (1995). 1 ancestor in all.
5 later devices descend from it; 5 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945940: Coatest (R) Apc (TM) Resistance, Axis-Shield Doc AS (1995) Summary page 1.

## Most influential descendants
- K260551: HemosIL Factor V Leiden (APC Resistance V) (2026), 0 descendants of its own
- K083729: Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act. PC-R Control Plasma and Biophen (2009), 0 descendants of its own
- K042760: Pefakit Apc-R Factor V Leiden Controls (2004), 0 descendants of its own
- K042762: Pefakit Apc-R Factor V Leiden (2004), 0 descendants of its own
- K042333: Control Plasma N, Proc Control Plasma (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K963111
Methodology: https://510kreport.com/methodology