Shanghai Venture Bio-Tech Co., Ltd. · Class II · Cleared Dec 17, 2018
| K-number | K180878 |
| Device name | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx |
| Applicant | Shanghai Venture Bio-Tech Co., Ltd. |
| Product code | DJC |
| Device class | Class II |
| Decision date | Dec 17, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 862.3610 |
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