# K983119: Entero-Test HP, Model #102-01

- Pathway: 510(k) (Traditional)
- Applicant: Hdc Corp.
- Decided: Mar 15, 1999 after 188 days
- Product code: LIO (Device, Specimen Collection)
- Device class: 1
- Regulation: 21 CFR 866.2900
- 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. The FDA summary names its predicate without a number.
- (no number) Entero-Test®: named in the summary without a submission number
- (no number) Entero-Test® Pediatric: named in the summary without a submission number

## Indications for use
The Entero-Test® HP is an in-vitro diagnostic device indicated for the collection of fluids/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceuttwl capsule.

Source page: https://510kreport.com/device/K983119
Methodology: https://510kreport.com/methodology