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FDA 510(k) Applications Submitted by Yan Hua
FDA 510(k) Number
Submission Date
Device Name
Applicant
K250398
02/12/2025
Innovita Flu A/B Antigen Rapid Test
Innovita (Tangshan) Biological Technology CO., LTD
K241919
07/01/2024
Innovita HCG Pregnancy Rapid Combo Test
Innovita (Tangshan) Biological Technology CO., LTD
K210578
02/26/2021
Medical Nitrile Examination Gloves (Power free, Blue)
Jiangxi Hongda Medical Equipment Group Ltd.
K210821
03/19/2021
Medical PVC Examination Gloves
Jiangxi Hongda Medical Equipment Group Ltd.
K163161
11/10/2016
Sterile Single-use Syringe with Needle
JiangXi HongDa Medical Equipment Group Ltd.
K163162
11/10/2016
Sterile Hypodermic Safety Syringes for Single Use
JiangXi HongDa Medical Equipment Group Ltd.
K201324
05/18/2020
Antibacterial Bandage
Jiangsu Excellence Medical Supplies Co., Ltd
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