# K981305: Olympus Serum Protein Multicalibrator

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: May 7, 1998 after 27 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 Serum Protein Multicalibrator is designed for use in Olympus automated clinical chemistry analyzers for IgG, IgA, IeM, C3, C4, Transferrin, Ferntin, CRP, and ASO determinations.

Source page: https://510kreport.com/device/K981305
Methodology: https://510kreport.com/methodology