Advin Biotech, Inc.
San Diego, CA, US
ADVIN BIOTECH, INC. appears in FDA device records in San Diego, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Advin Biotech, Inc. between 2013 and 2025. The busiest year on record is 2013, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | NFT | Substantially Equivalent | |
| K201494 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | DJG | Substantially Equivalent | |
| K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | DJG | Substantially Equivalent | |
| K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | DKZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010934853 | 3010934853 | ADVIN BIOTECH, INC. | 10140 Mesa Rim Rd., Unit 1, San Diego, CA 92121 US | 2026 | and 29 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QKPCoronavirus Antigen Detection Test System.
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- OHQMulti-Analyte Controls Unassayed
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- QKOReagent, Coronavirus Serological
- MRSTest System, Nicotine, Cotinine, Metabolites
- PUXTest, Amphetamine, Employment And Insurance Testing, Exempt
- NFTTest, Amphetamine, Over The Counter
- PUYTest, Barbiturate, Employment And Insurance Testing, Exempt
- PTHTest, Barbiturate, Over The Counter
- PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt
- NFVTest, Benzodiazepine, Over The Counter
- PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt
- NFWTest, Cannabinoid, Over The Counter
- PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
- PVBTest, Codeine, Employment And Insurance Testing, Exempt
- PVETest, Methadone, Employment And Insurance Testing, Exempt
- PTGTest, Methadone, Over The Counter
- PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt
- NGGTest, Methamphetamine, Over The Counter
- PVFTest, Methaqualone, Employment And Insurance Testing, Exempt
- PVGTest, Morphine, Employment And Insurance Testing, Exempt
- PVHTest, Opiates, Employment And Insurance Testing, Exempt
- NGLTest, Opiates, Over The Counter
- NGMTest, Phencyclidine (Pcp), Over The Counter
- PVITest, Propoxyphene, Employment And Insurance Testing, Exempt
- QBFTest, Propoxyphene, Over The Counter
- QAWTest, Tricyclic Antidepressants, Over The Counter
- DJCThin Layer Chromatography, Methamphetamine
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain