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
06974246461762	K191924	000
06974246461434	K191924	000
06974246461441	K191924	000
06974246461458	K191924	000
06974246461304	K191924	000
06974246460956	K191924	000
06974246460963	K191924	000
06974246460970	K191924	000
06974246460949	K191924	000
06974246460567	K191924	000
06974246460680	K191924	000
06974246461755	K191924	000