# K991136: B-2-Microglobulin Immunological Test System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: May 11, 1999 after 36 days
- Product code: JZG (System, Test, Beta-2-Microglobulin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5630
- 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
- K161297: Beta-2-Microglobulin (2016), 0 descendants of its own

## Indications for use
The Olympds Beta-2-Microglobulin reagent is intended for use oi Olympus Clinical Chemistry Analzyers for the quantitative determination-of Beta-2-Microglobulin in human serum. Measurements of the amount of Beta-2-Microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Source page: https://510kreport.com/device/K991136
Methodology: https://510kreport.com/methodology