FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PICCOLO MAGNESIUM TEST SYSTEM
K Number: K040115
·
Decision Jan 30, 2004
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
89
Applicant Total
20
Review Days
10
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PICCOLO MAGNESIUM TEST SYSTEM
- K Number
- K040115
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abaxis, Inc.
- Date Received
- January 20, 2004
- Decision Date
- January 30, 2004
- Product Code
- JGJ
- 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 |
|---|---|---|---|
| JGJ | Photometric Method, Magnesium | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGJ), ordered by most recent decision date.
Magnesium
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Magnesium
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Randox RX Daytona Plus Magnesium (MG)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Atellica CH Magnesium (Mg)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACE MAGNESIUM REGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MAGNESIUM ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |
| K120664 | PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM | Apr 24, 2012 | 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 |
| K023640 | PICCOLO HDL TEST SYSTEM | Jan 24, 2003 | Substantially Equivalent |
| K023642 | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM | Jan 24, 2003 | Substantially Equivalent |