FDA Product Code SCL: Allergen And Vaccine Delivery Needles
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.
Leading manufacturers include Univec, Inc., Bd and Becton, Dickinson & CO.
25
Total
25
Cleared
139d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
305d
recently vs 133d historically
FDA 510(k) Cleared Allergen And Vaccine Delivery Needles Devices (Product Code SCL)
25 devices
Cleared
Jan 30, 2026
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
Asistan Medikal
General Hospital
305d
Cleared
Dec 06, 2022
Bifurcated Needle
Anhui Tiankang Medical Technology Co., Ltd.
General Hospital
120d
Cleared
Apr 10, 2019
Oryum and Ovem Epidermal Deri Prick Test Applicator
Allergy & Applicator Depot, LLC
General Hospital
203d
Cleared
Mar 05, 2018
AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
Medscience Science Research Group, Inc.
General Hospital
241d
Cleared
Aug 17, 2017
Allerhope Allergy Skin Tester
Procare Industrial Co., Limited
General Hospital
303d
Cleared
Sep 09, 2003
BD ECLIPSE BIFURCATED NEEDLE
Becton, Dickinson & CO
General Hospital
25d
Cleared
Mar 20, 2002
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
Bd
General Hospital
29d
Cleared
Mar 19, 2002
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
Univec, Inc.
General Hospital
33d
Cleared
Sep 19, 2001
BIFURCATED VACCINATING NEEDLE
Precision Medical Products, Inc.
General Hospital
44d
Cleared
Sep 14, 2001
ALLERSHARP ALLERGY SKIN TESTER
Hmb Medical Concepts, Ltd.
General Hospital
81d
Cleared
Dec 13, 2000
GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
Greer Laboratories, Inc.
General Hospital
62d
Cleared
Apr 28, 2000
DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D
Biomedex, Inc.
General Hospital
88d
Cleared
Sep 02, 1998
QUANTI-TEST SYSTEM
Panatrex, Inc.
General Hospital
41d
Cleared
Aug 07, 1996
MULTI-TEST II
Lincoln Diagnostics, Inc.
General Hospital
82d
Cleared
Nov 13, 1995
QUINTEST
Bayer Corp.
General Hospital
90d
About Product Code SCL - Regulatory Context
510(k) Submission Activity
25 total 510(k) submissions under product code SCL since 1976, with 25 receiving FDA clearance (average review time: 139 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - SCL Product Code
Recent submissions under SCL have taken an average of 305 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
SCL devices are reviewed by the General Hospital panel. Browse all General Hospital devices →