FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A-GENT CARBAMAZEPINE
K Number: K832631
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
55
Applicant Total
883
Review Days
39
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Basic Information
- Device Name
- A-GENT CARBAMAZEPINE
- K Number
- K832631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- August 4, 1983
- Decision Date
- September 12, 1983
- Product Code
- KLT
- 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 |
|---|---|---|---|
| KLT | Enzyme Immunoassay, Carbamazepine | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLT), ordered by most recent decision date.
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FDA Class 2
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