# K915083: Coamate (R) Antithrombin Chromogenic Assay

- Pathway: 510(k) (Traditional)
- Applicant: Kabi Pharmacia, Inc.
- Decided: Jan 3, 1992 after 52 days
- Product code: JBQ (Antithrombin Iii Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980499: IL Test Antithrombin (1998), 9 descendants of its own
- K994238: IL Test Liquid Antithrombin (2000), 4 descendants of its own
- K033775: Hemosil Liquid Antithrombin XL (2004), 2 descendants of its own
- K022195: Coamatic at-400 (2002), 2 descendants of its own
- K062431: Hemosil Liquid Antithrombin (2006), 1 descendant of its own

Source page: https://510kreport.com/device/K915083
Methodology: https://510kreport.com/methodology