# K161329: Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel

- Pathway: 510(k) (Special)
- Applicant: Chrono-Log Corp.
- Decided: Dec 2, 2016 after 204 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
Longest line of descent: 4 generations back to K830749 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050265: Chrono-Log Whole Blood Lumi-Aggregometer, Model 700, Chrono-Log Corp. (2005) Summary page 5.

## Indications for use
The Chrono-log Model 490 4+4 Aggregometer is intended for use for in-vitro diagnostic use for measuring Platelet Aggregation in Platelet Rich Plasma. This device is intended to be used in a clinical laboratory environment by laboratory technicians. For use only with light transmission aggregometry assays cleared for use with the Chrono-log Platelet Aggregometry systems.

Source page: https://510kreport.com/device/K161329
Methodology: https://510kreport.com/methodology