The following data is part of a premarket notification filed by Safecare Biotech (hangzhou)co.,ltd. with the FDA for Safecare Urine Test Amphetamine, Safecare Urine Test Cocaine, Safecare Urine Test Marijuana.
| Device ID | K153646 |
| 510k Number | K153646 |
| Device Name: | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | SAFECARE BIOTECH (HANGZHOU)CO.,LTD. BUILDING 2/203 NO.18 HAISHU RD., CANGQIAN SUB-DISTRICT, YUHANG DISTRICT Hangzhou, CN 311121 |
| Contact | Alex Qiu |
| Correspondent | Joe Shia LSI INTERNATIONAL 504 E DIAMOND AVE SUITE.I Gaithersburg, MD 20877 |
| Product Code | DIO |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974246460802 | K153646 | 000 |
| 06974246460857 | K153646 | 000 |