Medical Device Manufacturer · CN , Shanghai

Shanghai Venture Bio-Tech Co., Ltd.

2 submissions · 2 cleared · Since 2018
2
Total
2
Cleared
0
Denied

Shanghai Venture Bio-Tech Co., Ltd. — FDA 510(k) Submissions

Shanghai Venture Bio-Tech Co., Ltd. has submitted 2 FDA 510(k) premarket notifications since 2018, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thin Layer Chromatography, Methamphetamine, Enzyme Immunoassay, Amphetamine . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
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
K180878 · DJC Thin Layer... · Toxicology
Dec 2018 258d
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
K180879 · DKZ Enzyme Immunoassay,... · Toxicology
Dec 2018 255d
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