FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPQ CRP CONTROL LEVEL II
K Number: K935075
·
Decision Jan 11, 1994
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
69
Applicant Total
58
Review Days
78
Basic Information
- Device Name
- SPQ CRP CONTROL LEVEL II
- K Number
- K935075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INCSTAR CORP.
- Date Received
- October 25, 1993
- Decision Date
- January 11, 1994
- Product Code
- DCN
- 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
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