FDA Product Code CGL: Electrode, Ion Based, Enzymatic, Creatinine
Leading manufacturers include Nova Biomedical Corp., Radiometer Medical Aps and Nova Biomedical Corporation.
8
Total
8
Cleared
168d
Avg days
1991
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
88d
recently vs 180d historically
FDA 510(k) Cleared Electrode, Ion Based, Enzymatic, Creatinine Devices (Product Code CGL)
8 devices
Cleared
Jun 26, 2026
i-STAT Crea cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Chemistry
88d
Cleared
May 26, 2017
Nova StatSensor Creatinine Hospital Meter System
Nova Biomedical Corporation
Chemistry
46d
Cleared
May 07, 2007
NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS
Nova Biomedical Corp.
Chemistry
119d
Cleared
Oct 16, 2006
ABL8X7 FLEX
Radiometer Medical Aps
Chemistry
453d
Cleared
Jul 16, 1999
STAT PROFILE M7 ANALYZER
Nova Biomedical Corp.
Chemistry
57d
About Product Code CGL - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code CGL since 1991, with 8 receiving FDA clearance (average review time: 168 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - CGL Product Code
Recent submissions under CGL have taken an average of 88 days to reach a decision - down from 180 days historically, suggesting improved FDA processing for this classification.
CGL devices are reviewed by the Chemistry panel. Browse all Chemistry devices →