FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K Number: K002651
·
Decision Oct 13, 2000
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
74
Review Days
49
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Basic Information
- Device Name
- C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
- K Number
- K002651
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pointe Scientific, Inc.,
- Date Received
- August 25, 2000
- Decision Date
- October 13, 2000
- Product Code
- DCK
- Advisory Committee
- Immunology
- Review Advisory Committee
- CH
- 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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| K051646 | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH | Oct 7, 2005 | Substantially Equivalent |
| K040391 | TOTAL BILIRUBIN REAGENT SET | Jun 2, 2004 | Substantially Equivalent |
| K031539 | HEMOGLOBIN A1C REAGENT SET | Aug 6, 2003 | Substantially Equivalent |
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