FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
K Number: K151395
·
Decision Jul 24, 2015
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
62
Applicant Total
50
Review Days
59
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Basic Information
- Device Name
- Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
- K Number
- K151395
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3620
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunalysis Corporation
- Date Received
- May 26, 2015
- Decision Date
- July 24, 2015
- Product Code
- DJR
- 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 |
|---|---|---|---|
| DJR | Enzyme Immunoassay, Methadone | FDA class 2 | Clinical Toxicology |
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