FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FITC ANTI-RABIES MONOCLONAL GLOBULIN
K Number: K820499
·
Decision Apr 16, 1982
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
3
Review Days
52
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Basic Information
- Device Name
- FITC ANTI-RABIES MONOCLONAL GLOBULIN
- K Number
- K820499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3460
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Centocor, Inc.
- Date Received
- February 23, 1982
- Decision Date
- April 16, 1982
- Product Code
- GOI
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GOI | Antiserum, Fluorescent, Rabies Virus | FDA class 2 | Microbiology |
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