# K931172: Imx (R) Stat CK-MB

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 15, 1993 after 99 days
- Product code: JHY (Colorimetric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
58 later devices descend from it; 1 cites it directly.
0 of 59 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
- K961501: Elecsys CK-MB (1996), 57 descendants of its own
- K962575: Elecsys Precicontrol Cardiac (1996), 52 descendants of its own
- K983492: Boehringer Mannheim Elecsys Presicontrol Cardiac (1998), 51 descendants of its own
- K032089: Roche Diagnostics Elecsys Precicontrol Cardiac (2003), 41 descendants of its own
- K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset (2008), 20 descendants of its own

Source page: https://510kreport.com/device/K931172
Methodology: https://510kreport.com/methodology