FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
RANDOX VALPROIC ACID
K Number: K011649
·
Decision Jan 15, 2002
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
34
Applicant Total
116
Review Days
231
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Basic Information
- Device Name
- RANDOX VALPROIC ACID
- K Number
- K011649
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- May 29, 2001
- Decision Date
- January 15, 2002
- Product Code
- LEG
- 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 |
|---|---|---|---|
| LEG | Enzyme Immunoassay, Valproic Acid | FDA class 2 | Clinical Toxicology |
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