Cleared Traditional

BIFURCATED ALLERGY SKIN TESTING NEEDLE

K031630 · Precision Medical Products, Inc. · General Hospital

Aug 2003

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K031630 is an FDA 510(k) clearance for the BIFURCATED ALLERGY SKIN TESTING NEEDLE, a Allergen And Vaccine Delivery Needles (Class II — Special Controls, product code SCL), submitted by Precision Medical Products, Inc. (Denver, US). The FDA issued a Cleared decision on August 7, 2003, 72 days after receiving the submission on May 27, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K031630 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2003
Decision Date	August 07, 2003
Days to Decision	72 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

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.