# K961412: CK-MB Method for the Technicon Immuno 1 System in-Vitro

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jun 18, 1996 after 67 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
This in vitro diagnostic procedure is a solid- phase enzyme immunoassay intended for the quantitative determination of CK-MB in human serum or plasma on the Technicon Immuno 1 system. When used in combination with other clinical data such as presenting symptoms and EKG values, measurement of CK-MB aids in the diagnosis of acute myocardial infarction.

Source page: https://510kreport.com/device/K961412
Methodology: https://510kreport.com/methodology