CGL — Electrode, Ion Based, Enzymatic, Creatinine Class II
FDA Device Classification
Classification Details
- Product Code
- CGL
- Device Class
- Class II
- Regulation Number
- 862.1225
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K171059 | nova biomedical corporation | Nova StatSensor Creatinine Hospital Meter System | May 26, 2017 |
| K113726 | epocal | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | October 5, 2012 |
| K070068 | nova biomedical | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS | May 7, 2007 |
| K051968 | radiometer medical aps | ABL8X7 FLEX | October 16, 2006 |
| K991727 | nova biomedical | STAT PROFILE M7 ANALYZER | July 16, 1999 |
| K973292 | i-stat | I-STAT SYSTEM | October 20, 1997 |
| K903034 | swedish trade council usa | RENALYZER PRX 90 | March 13, 1991 |