# K883147: Trace Elements Serum Toxicology Control

- Pathway: 510(k) (Traditional)
- Applicant: Utak Laboratories, Inc.
- Decided: Oct 6, 1988 after 72 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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
- Mar 20, 2020 · Class III · Z-2407-2020: The product has an incorrect reference value for cadmium and an incorrect expected range.

Source page: https://510kreport.com/device/K883147
Methodology: https://510kreport.com/methodology