FDA.reportPublic FDA data

510(k) K222385

Device
Bifurcated Needle
Applicant
Anhui Tiankang Medical Technology Co., Ltd.
510(k) number
K222385
Product code
SCL
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-06
Date received
2022-08-08
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
No

Applicant Contact#

Contact
Zhang Yong
Address
# 228, Weiyi Rd., Economic Development Zone Tianchang CN 239300 239300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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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