Cleared Traditional

Oryum and Ovem Epidermal Deri Prick Test Applicator

K182582 · Allergy & Applicator Depot, LLC · General Hospital

Apr 2019

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K182582 is an FDA 510(k) clearance for the Oryum and Ovem Epidermal Deri Prick Test Applicator, a Allergen And Vaccine Delivery Needles (Class II — Special Controls, product code SCL), submitted by Allergy & Applicator Depot, LLC (Sound Beach, US). The FDA issued a Cleared decision on April 10, 2019, 203 days after receiving the submission on September 19, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K182582 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2018
Decision Date	April 10, 2019
Days to Decision	203 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	SCL — Allergen And Vaccine Delivery Needles
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5570
Definition	An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests.