FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
K Number: K962019
·
Decision Nov 25, 1996
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
51
Review Days
186
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Basic Information
- Device Name
- C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
- K Number
- K962019
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teco Diagnostics
- Date Received
- May 23, 1996
- Decision Date
- November 25, 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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