FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
K Number: K020148
·
Decision Feb 4, 2002
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
37
Applicant Total
21
Review Days
19
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Basic Information
- Device Name
- pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
- K Number
- K020148
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phoenix Diagnostics, Inc.
- Date Received
- January 16, 2002
- Decision Date
- February 4, 2002
- Product Code
- CGZ
- 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 |
|---|---|---|---|
| CGZ | Electrode, Ion-Specific, Chloride | FDA class 2 | Clinical Chemistry |
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Other Clearances by Phoenix Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023268 | PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS | Nov 15, 2002 | Substantially Equivalent |
| K020364 | PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS | Jun 4, 2002 | Substantially Equivalent |
| K020129 | PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE | Feb 1, 2002 | Substantially Equivalent |
| K013451 | PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES | Dec 18, 2001 | Substantially Equivalent |
| K012987 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER | Nov 7, 2001 | Substantially Equivalent |
| K012509 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM | Oct 9, 2001 | Substantially Equivalent |
| K960592 | ELECTROLYTE STANDARDS | May 13, 1996 | Substantially Equivalent |
| K945860 | SPECTRUM CO-OXIMETER LINEARITY CONTROL | Jan 17, 1995 | Substantially Equivalent |
| K920285 | BLOOD GAS/ISE LINEARITY CONTROL | Jul 14, 1992 | Substantially Equivalent |
| K912718 | ENZYME LINEARITY CONTROL | Sep 6, 1991 | Substantially Equivalent |