# K864271: IL Test 84673-30 Chromogenics Control Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Nov 25, 1986 after 27 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- 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.
6 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021024: Hemosil High Abnormal Control Assayed (2002), 3 descendants of its own
- K021022: Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed) (2002), 2 descendants of its own
- K082859: Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed (2008), 1 descendant of its own
- K173202: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set (2018), 0 descendants of its own
- K110432: Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K864271
Methodology: https://510kreport.com/methodology