Medical Device Manufacturer · CN , Guangzhou

Guangzhou Decheng Biotechnology Co., Ltd.

8 submissions · 8 cleared · Since 2022
8
Total
8
Cleared
0
Denied

Guangzhou Decheng Biotechnology Co., Ltd. — FDA 510(k) Submissions

Guangzhou Decheng Biotechnology Co., Ltd. has submitted 8 FDA 510(k) premarket notifications since 2022, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Kit, Test, Pregnancy, Hcg, Over The Counter, Test, Opiates, Over The Counter, Enzyme Immunoassay, Opiates . Use the specialty filter in the sidebar to narrow results.

8 devices
1–8 of 8
MissLan? Early Detection Digital Pregnancy Test; MissLan? Early Result Digital Pregnancy Test
K251040 · LCX Kit, Test, Pregnancy,... · Chemistry
Sep 2025 159d
Dochek? Multi-Drug Urine Test Cup; Dochek? Multi-Drug Urine Test Cup Pro
K250067 · NGL Test, Opiates, Over The... · Toxicology
Feb 2025 41d
Dochek? Fentanyl Urine Test Strip, Dochek? Fentanyl Urine Test Strip Plus, Dochek? Fentanyl Urine Test Card, Dochek? Fentanyl Urine Test Card Plus, Dochek? Fentanyl Urine Test Cup and Dochek? Fentanyl Urine Test Cup Plus
K242428 · NGL Test, Opiates, Over The... · Toxicology
Feb 2025 175d
MissLan? Early Detection Pregnancy Test Strip; MissLan? Early Detection Pregnancy Test Cassette; MissLan? Early Detection Pregnancy Test Midstream
K240643 · LCX Kit, Test, Pregnancy,... · Chemistry
Jun 2024 106d
Dochek? Multi-Drug Urine Test Dipcard Rx; Dochek? Multi-Drug Urine Test Dipcard
K240698 · DJG Enzyme Immunoassay, Opiates · Toxicology
May 2024 57d
Dochek? Multi-Drug Urine Test Cup Rx, Dochek? Multi-Drug Urine Test Cup
K232659 · DJG Enzyme Immunoassay, Opiates · Toxicology
Dec 2023 104d
MissLan? Pregnancy Rapid Test (Strip), MissLan? Pregnancy Rapid Test (Midstream)
K230038 · LCX Kit, Test, Pregnancy,... · Chemistry
Feb 2023 53d
MissLan? Digital Pregnancy Rapid Test
K222305 · LCX Kit, Test, Pregnancy,... · Chemistry
Nov 2022 121d
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