FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx
K Number: K230238
·
Decision Mar 31, 2023
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
5
Review Days
60
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Basic Information
- Device Name
- BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx
- K Number
- K230238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Bioeasy Biotechnology Co., Ltd.
- Date Received
- January 30, 2023
- Decision Date
- March 31, 2023
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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Other Clearances by Shenzhen Bioeasy Biotechnology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K193480 | BIOEASY Multi-Drug Test Cup | Jan 31, 2020 | Substantially Equivalent |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 | Oct 11, 2019 | Substantially Equivalent |
| K192301 | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip | Sep 20, 2019 | Substantially Equivalent |
| K182530 | BIOEASY Multi-Drug Test Cup | Nov 9, 2018 | Substantially Equivalent |