Company · CN
Safecare Biotech (Hangzhou) Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2025. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| NFW | Test, Cannabinoid, Over The Counter | 1 |
| NGG | Test, Methamphetamine, Over The Counter | 1 |
| NGL | Test, Opiates, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 10, 2025 | K242767 | Safecare Urinary Tract Infection Test Safecare Biotech (Hangzhou) Co., Ltd., CN | JMT |
| Apr 10, 2024 | K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette Safecare Biotech (Hangzhou) Co., Ltd., CN | NGL |
| Mar 24, 2021 | K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card Safecare Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Aug 13, 2020 | K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream Safecare Biotech (Hangzhou) Co., Ltd., CN | LCX |
| May 27, 2020 | K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card Safecare Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Aug 16, 2019 | K191924 | SAFECARE® THC Urine Strip Test Safecare Biotech (Hangzhou) Co., Ltd., CN | NFW |
| Nov 19, 2018 | K182654 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card Safecare Biotech (Hangzhou) Co., Ltd., CN | NGG |
| Aug 20, 2018 | K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card Safecare Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Mar 18, 2016 | K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana Safecare Biotech (Hangzhou) Co., Ltd., CN | DIO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||