Submission Details
| 510(k) Number | K191924 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 18, 2019 |
| Decision Date | August 16, 2019 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
SAFECARE? THC Urine Strip Test
Aug 2019
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K191924 is an FDA 510(k) clearance for the SAFECARE? THC Urine Strip Test, a Test, Cannabinoid, Over The Counter (Class II — Special Controls, product code NFW), submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 16, 2019, 29 days after receiving the submission on July 18, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.
Device Classification
| Product Code | NFW — Test, Cannabinoid, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3870 |
Manufacturer
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