# K001005: Wako HDL-C/LDL-C Calibrator

- Pathway: 510(k) (Special)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Jun 1, 2000 after 64 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 22, 2020 · Class III · Z-0932-2021: FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing

Source page: https://510kreport.com/device/K001005
Methodology: https://510kreport.com/methodology