# K921534: DSL Dhea (DSL 8900)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: May 26, 1992 after 56 days
- Product code: JKL (Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry)
- Device class: 1
- Regulation: 21 CFR 862.1060
- 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
- Sep 9, 2010 · Not classified · Z-2882-2011: The recall was initiated because Beckman Coulter has confirmed customer reports that DHEA measurements using DHEA RIA (REF DSL-8900) kit lots identified may overstate actual DHEA levels in patient sam

Source page: https://510kreport.com/device/K921534
Methodology: https://510kreport.com/methodology