# K993703: Clearview Easy HCG Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Unipath, Ltd.
- Decided: Dec 2, 1999 after 30 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CLEARVIEW EASY HCG Pregnancy Test, an in vitro diagnostic device, is intended to be used for the early detection of pregnancy via a urine test. The CLEARVIEW EASY HCG Test is a qualitative test which detects the hormone human chorionic gonadotrophin (hCG) in urine. It is for professional use and for use in the physician’s office.

Source page: https://510kreport.com/device/K993703
Methodology: https://510kreport.com/methodology