FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TDX KENAMYCIN
K Number: K822808
·
Decision Oct 8, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
883
Review Days
21
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Basic Information
- Device Name
- TDX KENAMYCIN
- K Number
- K822808
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3520
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- September 17, 1982
- Decision Date
- October 8, 1982
- Product Code
- KJI
- 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 |
|---|---|---|---|
| KJI | Radioimmunoassay, Kanamycin | FDA class 2 | Clinical Toxicology |
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