# K964156: Contrast Strip HCG

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Diagnostics
- Decided: Nov 25, 1996 after 40 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
Longest line of descent: 1 generation back to K952319 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952319: Contrast & Rapid HCG Urine/Serum TST, Medix Biotech, Inc. (1995) Summary page 1.

## Indications for use
The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy in physician’s office and clinical laboratories.

Source page: https://510kreport.com/device/K964156
Methodology: https://510kreport.com/methodology