CGL · Electrode, Ion Based, Enzymatic, Creatinine
Clinical Chemistry · 21 CFR 862.1225 · Class 2
Overview
| Product Code | CGL |
|---|---|
| Device Name | Electrode, Ion Based, Enzymatic, Creatinine |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Classification Rationale
Class II.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171059 | Nova StatSensor Creatinine Hospital Meter System | Nova Biomedical Corporation | May 26, 2017 | SESE |
| K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | Epocal, Inc. | Oct 5, 2012 | SESE |
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | Nova Biomedical Corp. | May 7, 2007 | SESE |
| K051968 | ABL8X7 FLEX | Radiometer Medical Aps | Oct 16, 2006 | SESE |
| K991727 | STAT PROFILE M7 ANALYZER | Nova Biomedical Corp. | Jul 16, 1999 | SESE |
| K973292 | I-STAT SYSTEM | I-Stat Corp. | Oct 20, 1997 | SESE |
| K903034 | RENALYZER PRX 90 | Swedish Trade Council USA | Mar 13, 1991 | SESE |
Top Applicants
- Nova Biomedical Corp. — 2 clearances
- Epocal, Inc. — 1 clearance
- I-Stat Corp. — 1 clearance
- Nova Biomedical Corporation — 1 clearance
- Radiometer Medical Aps — 1 clearance
