510(k) K240698

Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard by Guangzhou Decheng Biotechnology Co., Ltd. — Product Code DJG

K240698 is an FDA 510(k) premarket notification submitted by Guangzhou Decheng Biotechnology Co., Ltd. for the device "Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard". The FDA issued a decision of Substantially Equivalent on May 10, 2024. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Guangzhou Decheng Biotechnology Co., Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2024
Date Received
March 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type