FDA 510(k) Applications Submitted by Chen Li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240284 |
02/01/2024 |
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) |
Shenzhen Browiner Tech Co., Ltd |
| K221499 |
05/23/2022 |
Minimally Invasive Prostate Surgery Navigation System |
Augment Intelligent Medical System (China) Co., Ltd. |
| K242195 |
07/26/2024 |
Gemini Cervical Fusion Cage System |
ZheJiang Decans Medical Devices Co., Ltd. |
| K240563 |
02/29/2024 |
Power Wheelchair (JJW-6001) |
ZheJiang J&J Mobility Co., Ltd |
| K032461 |
08/11/2003 |
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 |
Lin-Zhi International, Inc. |
| K970795 |
03/04/1997 |
SHANG HO |
SHANG HO INDUSTRIAL CORP. LTD. |
| K964819 |
12/02/1996 |
SHENG HO |
SHANG HO INDUSTRIAL CORP. LTD. |
| K050733 |
03/17/2005 |
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
| K050945 |
04/14/2005 |
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS |
Lin-Zhi International, Inc. |
| K051058 |
04/26/2005 |
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
| K051088 |
04/28/2005 |
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
| K031797 |
06/10/2003 |
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) |
Lin-Zhi International, Inc. |
| K032365 |
07/31/2003 |
BENZODIAZEPINE ENZYME IMMUNOASSAY |
Lin-Zhi International, Inc. |
| K032764 |
09/05/2003 |
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) |
Lin-Zhi International, Inc. |
| K033094 |
09/29/2003 |
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) |
Lin-Zhi International, Inc. |
| K033866 |
12/12/2003 |
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) |
Lin-Zhi International, Inc. |
| K033885 |
12/15/2003 |
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) |
Lin-Zhi International, Inc. |
| K183041 |
11/01/2018 |
Full Digital Colour Doppler Ultrasonic Diagnostic System |
Wuhan Zoncare Bio-medical Electronics Co., Ltd |
| K181870 |
07/12/2018 |
Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use |
Wuhan W.E.O Science & Technology Development Co., Ltd. |
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