FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
RANDOX PHENOBARBITAL
K Number: K011303
·
Decision Jul 2, 2001
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
34
Applicant Total
116
Review Days
63
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Basic Information
- Device Name
- RANDOX PHENOBARBITAL
- K Number
- K011303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3660
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- April 30, 2001
- Decision Date
- July 2, 2001
- Product Code
- DLZ
- 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 |
|---|---|---|---|
| DLZ | Enzyme Immunoassay, Phenobarbital | FDA class 2 | Clinical Toxicology |
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