FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
K Number: K153646
·
Decision Mar 18, 2016
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
9
Review Days
88
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
- K Number
- K153646
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Safecare Biotech (Hangzhou) Co., Ltd.
- Date Received
- December 21, 2015
- Decision Date
- March 18, 2016
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIO), ordered by most recent decision date.
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRI Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRI Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Emit II Plus Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Safecare Biotech (Hangzhou) Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242767 | Safecare Urinary Tract Infection Test | Jan 10, 2025 | Substantially Equivalent |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | Apr 10, 2024 | Substantially Equivalent |
| K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | Mar 24, 2021 | Substantially Equivalent |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | Aug 13, 2020 | Substantially Equivalent |
| K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | May 27, 2020 | Substantially Equivalent |
| K191924 | SAFECARE® THC Urine Strip Test | Aug 16, 2019 | Substantially Equivalent |
| K182654 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | Nov 19, 2018 | Substantially Equivalent |
| K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | Aug 20, 2018 | Substantially Equivalent |