FDA.reportPublic FDA data

510(k) K250983

Device
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
Applicant
Asistan Medikal
510(k) number
K250983
Product code
SCL
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-30
Date received
2025-03-31
Regulation
880.5570
Classification name
Allergen And Vaccine Delivery Needles
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Ibrahim Muhittin Tuzcu
Address
Havaalani Organize Sanayi Bolgesi Korkun Mahallesi 103. Cadde No:6 Oguzeli, Gaziantep TR 2760 2760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SCL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222385Bifurcated NeedleAnhui Tiankang Medical Technology Co., Ltd.2022-12-06
K182582Oryum and Ovem Epidermal Deri Prick Test ApplicatorAllergy & Applicator Depot, LLC2019-04-10
K172062AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TrayMedscience Science Research Group, Inc.2018-03-05
K162917Allerhope Allergy Skin TesterProcare Industrial Co., Limited2017-08-17
K032528BD ECLIPSE BIFURCATED NEEDLEBecton, Dickinson & CO2003-09-09
K031630BIFURCATED ALLERGY SKIN TESTING NEEDLEPrecision Medical Products, Inc.2003-08-07
K020523BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757Bd2002-03-20
K020500UNIVEC BIFURCATED SLIDING SHEATH SYRINGEUnivec, Inc.2002-03-19
K012515BIFURCATED VACCINATING NEEDLEPrecision Medical Products, Inc.2001-09-19
K011979ALLERSHARP ALLERGY SKIN TESTERHmb Medical Concepts, Ltd.2001-09-14
K003195GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-ICGreer Laboratories, Inc.2000-12-13
K000299DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, DBiomedex, Inc.2000-04-28
K982578QUANTI-TEST SYSTEMPanatrex, Inc.1998-09-02
K961918MULTI-TEST IILincoln Diagnostics, Inc.1996-08-07
K953939QUINTESTBayer Corp.1995-11-13