510(k) K191924
K191924 is an FDA 510(k) premarket notification submitted by Safecare Biotech (Hangzhou) Co., Ltd. for the device "SAFECARE® THC Urine Strip Test". The FDA issued a decision of Substantially Equivalent on August 16, 2019. The device falls under product code NFW (Test, Cannabinoid, Over The Counter), a Class II device regulated under 21 CFR 862.3870. Safecare Biotech (Hangzhou) Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2019
- Date Received
- July 18, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Cannabinoid, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type