K191924 is an FDA 510(k) clearance for the SAFECARE® THC Urine Strip Test. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K191924 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | NFW - Test, Cannabinoid, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |