# K933269: Aia-Pack (R) Prog Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Oct 22, 1993 after 108 days
- Product code: JLS (Radioimmunoassay, Progesterone)
- Device class: 1
- Regulation: 21 CFR 862.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K153417: ST AIA-PACK PROG III Calibrator Set (2015), 0 descendants of its own
- K143144: ST AIA-PACK PROG II Calibrator Set (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K933269
Methodology: https://510kreport.com/methodology