FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine
K Number: K151557
·
Decision Jul 16, 2015
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
3
Applicant Total
2
Review Days
36
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Basic Information
- Device Name
- EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine
- K Number
- K151557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3640
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nantong Egens Biotech Co., Ltd.
- Date Received
- June 10, 2015
- Decision Date
- July 16, 2015
- Product Code
- DNK
- 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 |
|---|---|---|---|
| DNK | Thin Layer Chromatography, Morphine | FDA class 2 | Clinical Toxicology |
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Other Clearances by Nantong Egens Biotech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana | Nov 2, 2015 | Substantially Equivalent |