# K103409: Allergeaze R Clear

- Pathway: 510(k) (Traditional)
- Applicant: Smartpractice
- Decided: Mar 15, 2011 after 113 days
- Product code: KXF (Applicator, Absorbent Tipped, Non-Sterile)
- Device class: 1
- Regulation: 21 CFR 880.6025
- 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
allergEAZE clear Patch Test Chambers are an allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin. allergEAZE clear Patch Test Chambers are a intended for use by, or under the supervision of, a physician as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis.

Source page: https://510kreport.com/device/K103409
Methodology: https://510kreport.com/methodology