# K952319: Contrast & Rapid HCG Urine/Serum TST

- Pathway: 510(k) (Traditional)
- Applicant: Medix Biotech, Inc.
- Decided: Jun 20, 1995 after 33 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964155: Contrast HCG Urine/Serum Test and Rapid HCG Urine/Serum Test (1996), 0 descendants of its own
- K964156: Contrast Strip HCG (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K952319
Methodology: https://510kreport.com/methodology