# K945951: Quikpac II, One Step HCG Combo Kit

- Pathway: 510(k) (Traditional)
- Applicant: Syntron Bioresearch, Inc.
- Decided: Feb 8, 1995 after 64 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
- K984077: Instant-View Pregnancy Combo Test (1999), 0 descendants of its own
- K984080: Instant-View Pregnancy Combo Dip-Strip Test (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K945951
Methodology: https://510kreport.com/methodology