FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
K Number: K091052
·
Decision Jan 15, 2010
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
20
Review Days
277
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Basic Information
- Device Name
- PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
- K Number
- K091052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abaxis, Inc.
- Date Received
- April 13, 2009
- Decision Date
- January 15, 2010
- 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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|---|---|---|---|
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| K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | Feb 15, 2013 | Substantially Equivalent |
| K120664 | PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM | Apr 24, 2012 | Substantially Equivalent |
| K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM | Apr 24, 2012 | Substantially Equivalent |
| K091910 | PICCOLO MAGNESIUM TEST SYSTEM | Oct 1, 2009 | Substantially Equivalent |
| K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | Jul 8, 2005 | Substantially Equivalent |
| K040115 | PICCOLO MAGNESIUM TEST SYSTEM | Jan 30, 2004 | Substantially Equivalent |
| K023640 | PICCOLO HDL TEST SYSTEM | Jan 24, 2003 | Substantially Equivalent |
| K023642 | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM | Jan 24, 2003 | Substantially Equivalent |