FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
K Number: K120664
·
Decision Apr 24, 2012
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
21
Applicant Total
20
Review Days
50
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Basic Information
- Device Name
- PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
- K Number
- K120664
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abaxis, Inc.
- Date Received
- March 5, 2012
- Decision Date
- April 24, 2012
- Product Code
- JGY
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JGY | Colorimetric Method, Triglycerides | FDA class 1 | Clinical Chemistry |
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Other Clearances by Abaxis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200865 | Piccolo Potassium Test System | Oct 20, 2021 | Substantially Equivalent |
| K130113 | PICCOLO LACTATE TEST SYSTEM | Mar 11, 2013 | Substantially Equivalent |
| K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | Feb 15, 2013 | Substantially Equivalent |
| K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM | Apr 24, 2012 | Substantially Equivalent |
| K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | Jan 15, 2010 | 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 |