Submission Details
| 510(k) Number | K181968 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 2018 |
| Decision Date | August 20, 2018 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
Aug 2018
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K181968 is an FDA 510(k) clearance for the SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 20, 2018, 27 days after receiving the submission on July 24, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.
Device Classification
| Product Code | NFT — Test, Amphetamine, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3100 |
Manufacturer
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