FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYBREX VALPROIC ACID
K Number: K803236
·
Decision Jan 28, 1981
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
34
Applicant Total
883
Review Days
36
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Basic Information
- Device Name
- CYBREX VALPROIC ACID
- K Number
- K803236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- December 23, 1980
- Decision Date
- January 28, 1981
- 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 |
Similar 510(k) Clearances
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