FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
K Number: K922722
·
Decision Oct 5, 1992
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
5
Review Days
122
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Basic Information
- Device Name
- TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
- K Number
- K922722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Simplicity Diagnostics, Inc.
- Date Received
- June 5, 1992
- Decision Date
- October 5, 1992
- 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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Other Clearances by Simplicity Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970100 | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL | Mar 10, 1997 | Substantially Equivalent |
| K922725 | TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL | Oct 5, 1992 | Substantially Equivalent |
| K922726 | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL | Oct 5, 1992 | Substantially Equivalent |
| K922723 | TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL | Sep 18, 1992 | Substantially Equivalent |