FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXSYM TRICYCLIC ANTIDEPRESSANTS
K Number: K953761
·
Decision Nov 22, 1995
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
5
Applicant Total
883
Review Days
103
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Basic Information
- Device Name
- AXSYM TRICYCLIC ANTIDEPRESSANTS
- K Number
- K953761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3910
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- August 11, 1995
- Decision Date
- November 22, 1995
- Product Code
- LFH
- 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 |
|---|---|---|---|
| LFH | U.V. Spectrometry, Tricyclic Antidepressant Drugs | FDA class 2 | Clinical Toxicology |
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