# K952466: Olympus Apolipoprotein B Immunoturbidimetric Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Jun 5, 1995 after 10 days
- Product code: JHN (Turbidimetric Method, Lipoproteins)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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.
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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Apr 23, 2025 · Class III · Z-1815-2025: The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which co

Source page: https://510kreport.com/device/K952466
Methodology: https://510kreport.com/methodology