Product code CGL
- Device name
- Electrode, Ion Based, Enzymatic, Creatinine
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1225
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171059 | Nova StatSensor Creatinine Hospital Meter System | Nova Biomedical Corporation | 2017-05-26 |
| K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | Epocal, Inc. | 2012-10-05 |
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | Nova Biomedical Corp. | 2007-05-07 |
| K051968 | ABL8X7 FLEX | Radiometer Medical Aps | 2006-10-16 |
| K991727 | STAT PROFILE M7 ANALYZER | Nova Biomedical Corp. | 1999-07-16 |
| K973292 | I-STAT SYSTEM | I-Stat Corp. | 1997-10-20 |
| K903034 | RENALYZER PRX 90 | Swedish Trade Council USA | 1991-03-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10054749005519 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-05-01 |
| 00385480183420 | NOVA | NOVA BIOMEDICAL CORPORATION | 2017-04-24 |
| 00385480282413 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480379595 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480375627 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480375559 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480374132 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480367868 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480364591 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480362597 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480359429 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480248198 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480141826 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 10385480433706 | STATSENSOR | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 10385480528006 | STATSENSOR | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480170932 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480170925 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480142533 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364539 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364553 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364577 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480178792 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364614 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480127042 | NOVA/STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480367943 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480112727 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480095839 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480175142 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480379380 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480175180 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |