FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
K Number: K163704
·
Decision Aug 2, 2017
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
89
Applicant Total
27
Review Days
216
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Basic Information
- Device Name
- Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
- K Number
- K163704
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3170
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Healgen Scientific,, LLC
- Date Received
- December 29, 2016
- Decision Date
- August 2, 2017
- Product Code
- JXM
- 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 |
|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | FDA class 2 | Clinical Toxicology |
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FDA 510(k)
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·Clinical Toxicology
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