# P970038: Tandem-R Free Psa Immunoradiometric Assay/Tandem-MP Free Psa Immunoenzymetric Assay

- Pathway: PMA
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 10, 1998 after 193 days
- Product code: MTG (Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions)
- Device class: 3
- 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. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P970038
Methodology: https://510kreport.com/methodology