FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT
K Number: K834052
·
Decision Jan 24, 1984
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
55
Applicant Total
883
Review Days
62
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Basic Information
- Device Name
- CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT
- K Number
- K834052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- November 23, 1983
- Decision Date
- January 24, 1984
- 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
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