# K963080: Testosteronee Assay for the Technicon Immuno 1 System (in-Vitro Diagnostic System)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Sep 27, 1996 after 50 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- 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. The FDA summary names its predicate without a number.
- (no number) DPC Coat-2-Count® Total Testosterone RIA kit: named in the summary without a submission number

## Indications for use
This in vitro method is intended to quantitatively measure testosterone in human serum on a Technicon Immuno 1 system. Measurements of Testosterone are used in the diagnosis and treatment of various hormonal sexual disorders.

Source page: https://510kreport.com/device/K963080
Methodology: https://510kreport.com/methodology