Submission Details
| 510(k) Number | K153646 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 21, 2015 |
| Decision Date | March 18, 2016 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
Mar 2016
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K153646 is an FDA 510(k) clearance for the SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 18, 2016, 88 days after receiving the submission on December 21, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.
Device Classification
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3250 |
Manufacturer
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