Electrode, Ion Based, Enzymatic, Creatinine
The Electrode, Ion Based, Enzymatic, Creatinine test system (product code CGL) is an in-vitro diagnostic device used in clinical chemistry to measure creatinine concentrations in blood or urine using an ion-based electrode combined with an enzymatic reaction. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1225 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CGL
- Device Class
- FDA class 2
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K171059 | Nova StatSensor Creatinine Hospital Meter System | May 26, 2017 | Substantially Equivalent | Nova Biomedical Corporation |
| K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | Oct 05, 2012 | Substantially Equivalent | Epocal, Inc. |
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | May 07, 2007 | Substantially Equivalent | Nova Biomedical Corp. |
| K051968 | ABL8X7 FLEX | Oct 16, 2006 | Substantially Equivalent | Radiometer Medical Aps |
| K991727 | STAT PROFILE M7 ANALYZER | Jul 16, 1999 | Substantially Equivalent | Nova Biomedical Corp. |
| K973292 | I-STAT SYSTEM | Oct 20, 1997 | Substantially Equivalent | I-Stat Corp. |
| K903034 | RENALYZER PRX 90 | Mar 13, 1991 | Substantially Equivalent | Swedish Trade Council USA |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.