# K942566: Imx Ultrasensistive HTSH II

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 16, 1994 after 77 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- 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; 1 cites 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052301: Fastpack TSH Immunoassay (2006), 2 descendants of its own
- K123725: Fastpack Control Kit (2013), 0 descendants of its own
- K110761: Mict TSH (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K942566
Methodology: https://510kreport.com/methodology