# K172062: AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray

- Pathway: 510(k) (Traditional)
- Applicant: Medscience Science Research Group, Inc.
- Decided: Mar 5, 2018 after 241 days
- Product code: SCL (Allergen And Vaccine Delivery Needles)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K003195 (2000). 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)
- K003195: Greertrack Skin Testing System, Model GT-IT, GT-IC, Greer Laboratories, Inc. (2000) Summary page 6.

## Indications for use
The skin test applicator is used for conventional administration (percutaneous application of allergenic extracts directly onto the surface of the skin) of diagnostic allergen extracts for performing allergy skin tests on the typical sites (the back and the volar surfaces of the forearms) for hypersensitivity reactions in individuals suspected of having allergies. The test tray is intended to hold allergenic extracts in a convenient arrangement for storage and use by the clinician.

Source page: https://510kreport.com/device/K172062
Methodology: https://510kreport.com/methodology