Cleared Traditional

Allerhope Allergy Skin Tester

K162917 · Procare Industrial Co., Limited · General Hospital

Aug 2017

Decision

303d

Days

Class 2

Risk

About This 510(k) Submission

K162917 is an FDA 510(k) clearance for the Allerhope Allergy Skin Tester, a Allergen And Vaccine Delivery Needles (Class II — Special Controls, product code SCL), submitted by Procare Industrial Co., Limited (Zhengzhou, CN). The FDA issued a Cleared decision on August 17, 2017, 303 days after receiving the submission on October 18, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K162917 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2016
Decision Date	August 17, 2017
Days to Decision	303 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.