# K983649: Max-Act

- Pathway: 510(k) (Traditional)
- Applicant: Array Medical, Inc.
- Decided: Dec 11, 1998 after 56 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- 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 K964609 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964609: Actalyke Activated Clotting Time Test System/Clotting Time Tubes/Whole Blood QC Kit/Actalyke Electronic Clotting Tube, Array Medical, Inc. (1997) Summary page 1.

## Indications for use
The MAX-ACT Activated Clotting Time test tubes are intended for the measurement of the activated clotting time (ACT) test on Actalyke Models Al, AIP, A2, A2P, and on Hemochron Models 400,401,800,801, and 8000.

Source page: https://510kreport.com/device/K983649
Methodology: https://510kreport.com/methodology