FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TDX TRANSFERRIN DIAGNOSTIC KIT
K Number: K854416
·
Decision Feb 21, 1986
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
47
Applicant Total
883
Review Days
109
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Basic Information
- Device Name
- TDX TRANSFERRIN DIAGNOSTIC KIT
- K Number
- K854416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5880
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- November 4, 1985
- Decision Date
- February 21, 1986
- Product Code
- DDG
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DDG | Transferrin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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