FDA 510(k) Applications for Medical Device Product Code "LDH"
(System, Delivery, Allergen And Vaccine)

FDA 510(k) Number Applicant Device Name Decision Date
K182582 Allergy & Applicator Depot, LLC Oryum and Ovem Epidermal Deri Prick Test Applicator 04/10/2019
K222385 Anhui Tiankang Medical Technology Co., Ltd. Bifurcated Needle 12/06/2022
K020523 BD BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 03/20/2002
K032528 BECTON DICKINSON & CO. BD ECLIPSE BIFURCATED NEEDLE 09/09/2003
K000299 BIOMEDEX, INC. DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D 04/28/2000
K992553 DORMER LABORATORIES, INC. IQ CHAMBERS 04/12/2000
K013820 EPITEST LTD. OY FINN CHAMBER (R) 01/30/2002
K003195 GREER LABORATORIES, INC. GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC 12/13/2000
K011979 HMB MEDICAL CONCEPTS, LTD. ALLERSHARP ALLERGY SKIN TESTER 09/14/2001
K961918 LINCOLN DIAGNOSTICS, INC. MULTI-TEST II 08/07/1996
K172062 MedScience Science Research Group, Inc. AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray 03/05/2018
K982578 PANATREX, INC. QUANTI-TEST SYSTEM 09/02/1998
K031630 PRECISION MEDICAL PRODUCTS, INC. BIFURCATED ALLERGY SKIN TESTING NEEDLE 08/07/2003
K012515 PRECISION MEDICAL PRODUCTS, INC. BIFURCATED VACCINATING NEEDLE 09/19/2001
K162917 PROCARE INDUSTRIAL CO., LIMITED Allerhope Allergy Skin Tester 08/17/2017
K063160 SMART PRACTICE ALLERGEAZE PATCH TEST CHAMBERS 12/22/2006
K123184 SMART PRACTICE FINN CHAMBERS AQUA 12/19/2012
K103409 SMARTPRACTICE ALLERGEAZE R CLEAR 03/15/2011
K020500 UNIVEC, INC. UNIVEC BIFURCATED SLIDING SHEATH SYRINGE 03/19/2002


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