Assure Tech. (Hangzhou) Co., Ltd.
Hangzhou Zhejiang, CN
ASSURE TECH. (HANGZHOU) CO., LTD. appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. 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 7 510(k) clearances for Assure Tech. (Hangzhou) Co., Ltd. between 2016 and 2024. The busiest year on record is 2016, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233174 | FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream | LCX | Substantially Equivalent | |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | DJG | Substantially Equivalent | |
| K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | NFT | Substantially Equivalent | |
| K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | NFT | Substantially Equivalent | |
| K170049 | AssureTech Panel Dip Test, AssureTech Quick Cup Test | NFT | Substantially Equivalent | |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | DJC | Substantially Equivalent | |
| K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) | DKZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009585529 | 3009585529 | ASSURE TECH. (HANGZHOU) CO., LTD. | Building 4, No. 1418-50, Moganshan Road, Gongshu District, Hangzhou Zhejiang 310011 CN | 2026 | and 38 more, listed in full below |
| 3038560224 | 3038560224 | Assure Tech. (Hangzhou) Co., Ltd. | No.128, Chunting Road, Fuyang District, Hangzhou, 311400 Zhejiang P.R. China, Hangzhou Zhejiang 311400 CN | 2026 | and 38 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DJZDevices, Breath Trapping, Alcohol
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LAFGas Chromatography, Methamphetamine
- QKEImmunoassay, Pregnanediol Glucuronide, Over The Counter
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- QYTOver-The-Counter Covid-19 Antigen Test
- LNWPaper, Obstetric Ph
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- QKOReagent, Coronavirus Serological
- DFQSperm, Antigen, Antiserum, Control
- 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
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- 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
- PVKTest, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt
- QAWTest, Tricyclic Antidepressants, Over The Counter
- DJCThin Layer Chromatography, Methamphetamine
- DNKThin Layer Chromatography, Morphine
- JHIVisual, Pregnancy Hcg, Prescription Use
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