Atlas FDA

SCL

25 FDA 510(k) clearances · Product code

99 daysmedian time to decision
305 days90th percentile
25clearances measured

FDA profile

Official device name
Allergen And Vaccine Delivery Needles
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5570
Medical specialty
General Hospital
Flags
Third-party review eligible
FDA 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.
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RecordFirmDate
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) (K250983)Asistan Medikal2026-01-30
Bifurcated Needle (K222385)Anhui Tiankang Medical Technology Co., Ltd.2022-12-06
Oryum and Ovem Epidermal Deri Prick Test Applicator (K182582)Allergy & Applicator Depot, LLC2019-04-10
AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray (K172062)Medscience Science Research Group, Inc.2018-03-05
Allerhope Allergy Skin Tester (K162917)Procare Industrial Co., Limited2017-08-17
BD ECLIPSE BIFURCATED NEEDLE (K032528)Becton, Dickinson & CO2003-09-09
BIFURCATED ALLERGY SKIN TESTING NEEDLE (K031630)Precision Medical Products, Inc.2003-08-07
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 (K020523)Bd2002-03-20
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE (K020500)Univec, Inc.2002-03-19
BIFURCATED VACCINATING NEEDLE (K012515)Precision Medical Products, Inc.2001-09-19
ALLERSHARP ALLERGY SKIN TESTER (K011979)Hmb Medical Concepts, Ltd.2001-09-14
GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC (K003195)Greer Laboratories, Inc.2000-12-13
DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D (K000299)Biomedex, Inc.2000-04-28
QUANTI-TEST SYSTEM (K982578)Panatrex, Inc.1998-09-02
MULTI-TEST II (K961918)Lincoln Diagnostics, Inc.1996-08-07
QUINTEST (K953939)Bayer Corp.1995-11-13
DUOTIP-TEST (K941820)Lincoln Diagnostics, Inc.1994-09-02
DISPOSABLE MULTI-PUNCTURE APPLICATOR (K922177)Allergy Extract Co.1993-06-17
GREER DERMAPIK SYSTEM (K890360)Greer Laboratories, Inc.1989-06-23
DERMAPIK (K882360)Creative Scientific Equipment Corp.1988-08-09
HMB ALLERGOGEN SKIN PRICK TEST NEEDLE (K844221)Aller/Guard, Inc.1985-02-08
COMBO SKIN TEST READY TO USE TAPE (K842107)Combion Systems, Inc.1984-09-05
COMBION SKIN TEST - FOUR PRONG (K833999)Nicholas H. Maganias1984-09-05
ALLER-SCREEN SKIN TEST KIT (K791328)Aller-Screen, Inc.1980-05-30
MULTI-TEST (K760699)Lincoln Laboratories, Inc.1976-12-30

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Every clearance here is in the API, with alerts when new ones post.