# K934562: Ciba Corning Acs Testosterone Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Dec 10, 1993 after 85 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K021326: Vidas Testosterone (Tes), Model 30 418 (2002), 1 descendant of its own
- K141133: VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II (2015), 0 descendants of its own
- K133491: Advia Centaur Testosterone (Tsto) (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K934562
Methodology: https://510kreport.com/methodology