FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTOCOR CA 15-3 RIA MODEL NO. 800-033
K Number: K963803
·
Decision May 23, 1997
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
27
Applicant Total
3
Review Days
242
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Basic Information
- Device Name
- CENTOCOR CA 15-3 RIA MODEL NO. 800-033
- K Number
- K963803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Centocor, Inc.
- Date Received
- September 23, 1996
- Decision Date
- May 23, 1997
- Product Code
- MOI
- 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 |
|---|---|---|---|
| MOI | System, Test, Immunological, Antigen, Tumor | FDA class 2 | Immunology |
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