# K941797: Immulite SHBG

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Oct 31, 1994 after 202 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.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- K031717: Elecsys SHBG Immunoassay (2003), 4 descendants of its own
- K083867: Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind (2009), 2 descendants of its own
- K060818: Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models, 8K26-25, 8K26-01 (2007), 2 descendants of its own
- K233480: Access SHBG (2024), 0 descendants of its own
- K182521: FastPack IP Sex Hormone Binding Globulin Immunoassay (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K941797
Methodology: https://510kreport.com/methodology