FDA 510(k) Applications Submitted by Lyn Chen
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K181551 |
06/13/2018 |
DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette |
Runbio BioTech Co.,Ltd |
| K240334 |
02/05/2024 |
LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) |
Lagis Enterprise Co., Ltd. |
| K240648 |
03/07/2024 |
Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) |
Radiant Innovation Inc. |
| K111637 |
06/13/2011 |
INFRARED EAR THERMOMETER |
RADIANT INNOVATION, INC. |
| K243867 |
12/17/2024 |
LAGIS Suction Irrigation System |
Lagis Enterprise Co., Ltd. |
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