# K932084: Aia-Pack E2 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Nov 9, 1993 after 193 days
- Product code: CHP (Radioimmunoassay, Estradiol)
- Device class: 1
- Regulation: 21 CFR 862.1260
- Recalls of this device: none
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K160113: ST AIA-PACK hsE2 Calibrator Set (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K932084
Methodology: https://510kreport.com/methodology