FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT CARBAMAZEPINE ASSAY
K Number: K123518
·
Decision Jun 5, 2013
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
55
Applicant Total
21
Review Days
203
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Basic Information
- Device Name
- ABBOTT CARBAMAZEPINE ASSAY
- K Number
- K123518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microgenics Corporation
- Date Received
- November 14, 2012
- Decision Date
- June 5, 2013
- 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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CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
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ADVIA IMS CARBAMAZEPINE METHOD
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ONLINE TDM CARBAMAZEPINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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FDA 510(k)
FDA Class 2
·Clinical Toxicology
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