FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
K Number: K962373
·
Decision Jul 11, 1996
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
145
Review Days
21
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Basic Information
- Device Name
- N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
- K Number
- K962373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Behring Diagnostics, Inc.
- Date Received
- June 20, 1996
- Decision Date
- July 11, 1996
- Product Code
- DCK
- 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 |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | FDA class 2 | Immunology |
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