# K955440: Immulite SHBG (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Dec 21, 1995 after 59 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K150132: IMMULITE IGF Control Module, IMMULITE Gastrin Control Module (2015), 0 descendants of its own

## Recalls of this device
- Jan 31, 2017 · Class II · Z-2166-2017: Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8¿C, as published in the Instructions for Use 

Source page: https://510kreport.com/device/K955440
Methodology: https://510kreport.com/methodology