SAFECARE® THC Urine Strip Test

Test, Cannabinoid, Over The Counter

Safecare Biotech (Hangzhou) Co., Ltd.

The following data is part of a premarket notification filed by Safecare Biotech (hangzhou) Co., Ltd. with the FDA for Safecare® Thc Urine Strip Test.

Pre-market Notification Details

• Device ID: K191924
• 510k Number: K191924
• Device Name: SAFECARE® THC Urine Strip Test
• Classification: Test, Cannabinoid, Over The Counter
• Applicant: Safecare Biotech (Hangzhou) Co., Ltd. Building 2/203 No.18 Haishu Rd., Cangqian Sub-district, Yuhang District Hangzhou, CN 311121
• Contact: Alex Qiu
• Correspondent: Joe Shia; LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
• Product Code: NFW
• CFR Regulation Number: 862.3870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-07-18
• Decision Date: 2019-08-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06974246460772	K191924	000
06974246460680	K191924	000
06974246460567	K191924	000
06974246460949	K191924	000
06974246460970	K191924	000
06974246460963	K191924	000
06974246460956	K191924	000