# K070835: Olympus CK-MB Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Life & Material Science Europa GmbH (Irish
- Decided: Jun 4, 2007 after 69 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
Longest line of descent: 1 generation back to K971817 (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)
- K971817: Olympus CK-MB Reagent, Olympus America, Inc. (1997) Summary page 1.

## Indications for use
System reagent for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum and heparinized plasma on OLYMPUS analyzers Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Source page: https://510kreport.com/device/K070835
Methodology: https://510kreport.com/methodology