Hangzhou AllTest Biotech Co.,Ltd
Hangzhou Zhejiang, CN
Hangzhou AllTest Biotech Co.,Ltd appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 14 510(k) clearances between and , no PMA records and 3 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 14 510(k) clearances for Hangzhou AllTest Biotech Co.,Ltd between 2019 and 2026. The busiest year on record is 2025, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 5 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260342 | AllTest Strep A Rapid Test | GTY | Substantially Equivalent | |
| K252607 | AllTest Urinary Tract Infection Test | JMT | Substantially Equivalent | |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | LCX | Substantially Equivalent | |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | NFT | Substantially Equivalent | |
| K242576 | AllTest Viral Transport Medium | JSM | Substantially Equivalent | |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | NFT | Substantially Equivalent | |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | NFT | Substantially Equivalent | |
| K241978 | Shinetell Digital Pregnancy Test | LCX | Substantially Equivalent | |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | NFT | Substantially Equivalent | |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | DKZ | Substantially Equivalent | |
| K233417 | AllTest Fentanyl Urine Test Cassette | NGL | Substantially Equivalent | |
| K231698 | AllTest Fentanyl Rapid Test (Urine) | DJG | Substantially Equivalent | |
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | JHI | Substantially Equivalent | |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) | DKZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012073813 | 3012073813 | Hangzhou AllTest Biotech Co.,Ltd | No. 550, Yinhai Street, Hangzhou Zhejiang 310018 CN | 2026 | and 38 more, listed in full below |
| 3027519599 | 3027519599 | Hangzhou AllTest Biotech Co.,Ltd | #383, Qiaoxin Road, Xiasha Street, Qiantang District, Hangzhou Zhejiang 310018, CN | 2026 | and 38 more, listed in full below |
| 3043127647 | 3043127647 | Hangzhou AllTest Biotech Co.,Ltd | No.616 Dongwei Road, Qiantang District, Hangzhou Zhejiang 311222 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
- GTYAntigens, All Groups, Streptococcus Spp.
- JSMCulture Media, Non-Propagating Transport
- DJZDevices, Breath Trapping, Alcohol
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- 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
- LAFGas Chromatography, Methamphetamine
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- LNWPaper, Obstetric Ph
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- 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
- NGITest, Morphine, Over The Counter
- 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
- LJXTest, Urine Leukocyte
- 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