Panels › Clinical Chemistry › Product code CGL · Class 2
Electrode, Ion Based, Enzymatic, Creatinine
Regulation 862.1225
1510(k)s in 12 months (8 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in CGL
| Company | 510(k)s | Recalls |
|---|---|---|
| Nova Biomedical Corp. | 3 | 4 |
| Radiometer America Inc | 0 | 3 |
| Abbott Point of Care, Inc. | 1 | 1 |
| Epocal, Inc. | 1 | 0 |
| I-Stat Corp. | 1 | 0 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Radiometer Medical Aps | 1 | 0 |
| Swedish Trade Council USA | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE. Open, Classified |
CGL | K053110 |
| Mar 18, 2015 | Radiometer America Inc Crea A and B membranes, packaged 4 per box
Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2 Terminated |
CGL | K051968 |
| Feb 13, 2012 | Radiometer America Inc S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark
Product Usage:
The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 s Terminated |
CGL | K051968 |
| Nov 24, 2010 | Abbott Point of Care Inc. i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ. Terminated |
CGL | K973292 |
| Mar 5, 2010 | Radiometer America Inc Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box. Terminated |
CGL | K051968 |
| May 7, 2009 | Nova Biomedical Corporation Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer
Catalog # 35238
Intended for in vitro diagnostic use by health care professionals and for point-of-care Terminated |
CGL | K022746 |
| Feb 16, 2008 | Nova Biomedical Corporation Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454 Terminated |
CGL | K070068 |
| Feb 16, 2008 | Nova Biomedical Corporation Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454 Terminated |
CGL | K070068 |
| Feb 16, 2008 | Nova Biomedical Corporation Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2
P/N 9600, Nova Biomedical, Waltham, MA 02454 Terminated |
CGL | K070068 |
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