# K954997: Centocor Aggrestat, Collagen Reagent, Control Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Centocor, Inc.
- Decided: Jan 24, 1996 after 84 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K962426: Chrono-Log Whole Blood Aggregometer (Wba) 591/592 (1996), 4 descendants of its own
- K032951: Chrono-Log Whole Blood Aggregometer, Models 591A and 592A (2004), 3 descendants of its own
- K050265: Chrono-Log Whole Blood Lumi-Aggregometer, Model 700 (2005), 2 descendants of its own
- K161329: Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel (2016), 0 descendants of its own
- K103555: Multiplate 5.0 Aggregometer (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K954997
Methodology: https://510kreport.com/methodology