FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NYCOCARD CRP CONTROL
K Number: K014084
·
Decision Jan 7, 2002
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
11
Review Days
27
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Basic Information
- Device Name
- NYCOCARD CRP CONTROL
- K Number
- K014084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Primus Corp.
- Date Received
- December 11, 2001
- Decision Date
- January 7, 2002
- 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 Primus Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K062658 | PRIMUS A1CARE ASSAY | Nov 26, 2007 | Substantially Equivalent |
| K013787 | NYCOCARD CRP | May 14, 2002 | Substantially Equivalent |
| K994045 | PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 | Dec 21, 1999 | Substantially Equivalent |
| K992921 | PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II | Nov 12, 1999 | Substantially Equivalent |
| K955283 | PRIMUS VARIANT SYSTEM PVS99 | Mar 1, 1996 | Substantially Equivalent |
| K942009 | PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY | Sep 14, 1994 | Substantially Equivalent |
| K940008 | GLYCATED PROTEIN CALIBRATORS | May 9, 1994 | Substantially Equivalent |
| K940142 | GLYCATED PROTEIN CONTROLS | Apr 26, 1994 | Substantially Equivalent |
| K936204 | GLYCATED HEMOGLOBIN CALIBRATORS | Mar 22, 1994 | Substantially Equivalent |
| K940143 | GLYCATED HEMOGLOBIN CONTROLS | Mar 15, 1994 | Substantially Equivalent |