# K971817: Olympus CK-MB Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Jun 11, 1997 after 26 days
- Product code: JLB (Atp And Creatine Kinase (Enzymatic), Creatine)
- Device class: 1
- Regulation: 21 CFR 862.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070835: Olympus CK-MB Reagent (2007), 0 descendants of its own

## Indications for use
The Olympus Creatine Kinase MB reagent is for the quantitative determination of Creatine Kinase-§1B isoenzyme in human serum on Olympus analyzers.

Source page: https://510kreport.com/device/K971817
Methodology: https://510kreport.com/methodology