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SCL — Allergen And Vaccine Delivery Needles Class II

FDA Device Classification

Classification Details

Product Code
SCL
Device Class
Class II
Regulation Number
880.5570
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250983asistan medikalMedblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, ASJanuary 30, 2026
K222385anhui tiankang medical technology coBifurcated NeedleDecember 6, 2022
K182582allergy and applicator depotOryum and Ovem Epidermal Deri Prick Test ApplicatorApril 10, 2019
K172062medscience science research groupAllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well TesMarch 5, 2018
K162917procare industrial co., limitedAllerhope Allergy Skin TesterAugust 17, 2017
K032528becton, dickinson andBD ECLIPSE BIFURCATED NEEDLESeptember 9, 2003
K031630precision medical productsBIFURCATED ALLERGY SKIN TESTING NEEDLEAugust 7, 2003
K020523bdBD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757March 20, 2002
K020500univecUNIVEC BIFURCATED SLIDING SHEATH SYRINGEMarch 19, 2002
K012515precision medical productsBIFURCATED VACCINATING NEEDLESeptember 19, 2001
K011979hmb medical conceptsALLERSHARP ALLERGY SKIN TESTERSeptember 14, 2001
K003195greer laboratoriesGREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-ICDecember 13, 2000
K000299biomedexDERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTApril 28, 2000
K982578panatrexQUANTI-TEST SYSTEMSeptember 2, 1998
K961918lincoln diagnosticsMULTI-TEST IIAugust 7, 1996
K953939bayerQUINTESTNovember 13, 1995
K941820lincoln diagnosticsDUOTIP-TESTSeptember 2, 1994
K922177allergy extractDISPOSABLE MULTI-PUNCTURE APPLICATORJune 17, 1993
K890360greer laboratoriesGREER DERMAPIK SYSTEMJune 23, 1989
K882360creative scientific equipmentDERMAPIKAugust 9, 1988