Name: Predicase
Price: 199 USD

K-number	K240698
Device name	Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
Applicant	Guangzhou Decheng Biotechnology Co., Ltd.
Product code	DJG
Device class	Class II
Decision date	May 10, 2024
Decision	Substantially Equivalent
Regulation	862.3650

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard

Everything you need for a 510(k) submission. Nothing you don't.