# K944407: Olympus Magnesium Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Dec 27, 1994 after 110 days
- Product code: JGJ (Photometric Method, Magnesium)
- Device class: 1
- Regulation: 21 CFR 862.1495
- Recalls of this device: 1 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K111915: Magnesium Assay (2011), 0 descendants of its own

## Recalls of this device
- Dec 8, 2021 · Class II · Z-0692-2022: Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples

Source page: https://510kreport.com/device/K944407
Methodology: https://510kreport.com/methodology