# K972095: Immulite 2000 Psa

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Aug 22, 1997 after 79 days
- Product code: LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The DPC IMMULITE 2000 PSA kit is intended for the quantitative measurement of prostate specific antigen (PSA) in human serum as an adjunctive test to aid in the management of prostate cancer in patients.

Source page: https://510kreport.com/device/K972095
Methodology: https://510kreport.com/methodology