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

FDA 510(k) Number Applicant Device Name Decision Date
K791328 ALLER-SCREEN, INC. ALLER-SCREEN SKIN TEST KIT 05/30/1980
K844221 ALLER/GUARD, INC. HMB ALLERGOGEN SKIN PRICK TEST NEEDLE 02/08/1985
K922177 ALLERGY EXTRACT CO. DISPOSABLE MULTI-PUNCTURE APPLICATOR 06/17/1993
K875227 ALLERTECH, INC. STERILE EMPTY VIALS 03/04/1988
K953939 BAYER CORP. QUINTEST 11/13/1995
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
K842107 COMBION SYSTEMS, INC. COMBO SKIN TEST READY TO USE TAPE 09/05/1984
K882360 CREATIVE SCIENTIFIC EQUIPMENT CORP. DERMAPIK 08/09/1988
K992553 DORMER LABORATORIES, INC. IQ CHAMBERS 04/12/2000
K013820 EPITEST LTD. OY FINN CHAMBER (R) 01/30/2002
K883686 FARRIS LABORATORIES, INC. STERILE EMPTY GLASS VIALS 09/23/1988
K890360 GREER LABORATORIES, INC. GREER DERMAPIK SYSTEM 06/23/1989
K003195 GREER LABORATORIES, INC. GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC 12/13/2000
K811365 HILL TOP RESEARCH, INC. HILL TOP CHAMBER 08/20/1981
K011979 HMB MEDICAL CONCEPTS, LTD. ALLERSHARP ALLERGY SKIN TESTER 09/14/2001
K941820 LINCOLN DIAGNOSTICS, INC. DUOTIP-TEST 09/02/1994
K961918 LINCOLN DIAGNOSTICS, INC. MULTI-TEST II 08/07/1996
K760699 LINCOLN LABORATORIES, INC. MULTI-TEST 12/30/1976
K172062 MedScience Science Research Group, Inc. AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray 03/05/2018
K833999 NICHOLAS H. MAGANIAS COMBION SKIN TEST - FOUR PRONG 09/05/1984
K926201 OSTEONICS CORP. OSTEONICS MICROSUTERED FEMORAL COMPONENTES 06/22/1993
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
K950822 SOLOPAK LABORATORIES, INC. SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL 03/22/1995
K020500 UNIVEC, INC. UNIVEC BIFURCATED SLIDING SHEATH SYRINGE 03/19/2002


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact