# K900940: TDX Phencyclidine II Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 25, 1990 after 56 days
- Product code: LCM (Enzyme Immunoassay, Phencyclidine)
- Device class: U
- 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
- Nov 17, 2003 · Not classified · Z-0279-04: The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges

Source page: https://510kreport.com/device/K900940
Methodology: https://510kreport.com/methodology