# K984145: Olympus Myoglobin Immunoturbidmetric Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Diagnostica GmbH
- Decided: Dec 23, 1998 after 34 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Olympus Myoglobin reagent is intended to be utilized for the quantitative determination of myoglobin in human serum on Olympus analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Source page: https://510kreport.com/device/K984145
Methodology: https://510kreport.com/methodology