FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TDX DIGOXIN
K Number: K820154
·
Decision Feb 5, 1982
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
14
Applicant Total
883
Review Days
17
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Basic Information
- Device Name
- TDX DIGOXIN
- K Number
- K820154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- January 19, 1982
- Decision Date
- February 5, 1982
- Product Code
- LCS
- 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 |
|---|---|---|---|
| LCS | Radioimmunoassay, Digoxin (125-I) | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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