# K003195: Greertrack Skin Testing System, Model GT-IT, GT-IC

- Pathway: 510(k) (Traditional)
- Applicant: Greer Laboratories, Inc.
- Decided: Dec 13, 2000 after 62 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) GreerPICK (DermaPICK) Skin Test Device: named in the summary without a submission number

## Most influential descendants
- K172062: AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray (2018), 0 descendants of its own

## Indications for use
The device system is for use in the prick/puncture application of allergen extracts to the epicutaneous layer of the skin in the performance of skin testing for immediate type hypersensitivity reactions in those individuals suspected of having allergies.

Source page: https://510kreport.com/device/K003195
Methodology: https://510kreport.com/methodology