Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and Test Strips
FDA 510(k) K070068 · Nova Biomedical Corp.
510(k) numberK070068
Submission
- Device name
- Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and Test Strips
- Applicant
- Nova Biomedical Corp.
Walham, MA, US - Received
- January 8, 2007
- Decision date
- May 7, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGL – Electrode, Ion Based, Enzymatic, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261039 | i-STAT Crea cartridge with the i-STAT 1 SystemCGL · Traditional | Abbott Point of Care, Inc. | 06/26/2026SE |
| K171059 | Nova StatSensor Creatinine Hospital Meter SystemCGL · Special | Nova Biomedical Corporation | 05/26/2017SE |
| K113726 | Epoc Chloride Test and Epoc Creatinine TestCGL · Traditional | Epocal, Inc. | 10/05/2012SE |
| K051968 | ABL8X7 FlexCGL · Traditional | Radiometer Medical Aps | 10/16/2006SE |
| K991727 | Stat Profile M7 AnalyzerCGL · Traditional | Nova Biomedical Corp. | 07/16/1999SE |
| K973292 | I-Stat SystemCGL · Traditional | I-Stat Corp. | 10/20/1997SE |
| K903034 | Renalyzer PRX 90CGL · Traditional | Swedish Trade Council USA | 03/13/1991SE |
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| K232075 | StatStrip Glucose Hospital Meter SystemPZI · Dual Track | 02/23/2024SE |
| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | 09/29/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | 10/18/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | 04/14/2020SE |
| K200204 | Stat Profile Prime Plus Analyzer SystemGGZ · Traditional | 04/06/2020SE |
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Questions and answers
When was Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and Test Strips cleared by the FDA?
Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and Test Strips (K070068) received a 510(k) decision of Substantially Equivalent on May 7, 2007, 119 days after the submission was received.
What is the product code of K070068?
The FDA product code is CGL – Electrode, Ion Based, Enzymatic, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.