# K964461: One -Step Urine/Serum Combo Pregnancy Card Test

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Feb 11, 1997 after 96 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K123844: Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test,  and HCG Combo Serum/Urine Cassette Test (2013), 0 descendants of its own
- K112101: Fastep HCG Pregancy Serum/Urine Cassette and Dipstick Tests (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K964461
Methodology: https://510kreport.com/methodology