Easygluco, Model IGM-0002 G2
FDA 510(k) K061431 · U. S. Diagnostics, Inc.
510(k) numberK061431
Submission
- Device name
- Easygluco, Model IGM-0002 G2
- Applicant
- U. S. Diagnostics, Inc.
New York, NY, US - Received
- May 24, 2006
- Decision date
- January 12, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252488 | ABL90 FLEX PLUS SystemCGA · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K210933 | YSI 2900C Biochemistry AnalyzerCGA · Traditional | Ysi, Inc. | 09/30/2024SE |
| K220328 | EasyStat 300CGA · Traditional | Medica Corporation | 07/26/2024SE |
| K223179 | Cholestech LDX SystemCGA · Dual Track | Alere San Diego, Inc. | 09/20/2023SE |
| K223755 | i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 09/11/2023SE |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 07/28/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | Instrumentation Laboratory CO | 01/27/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 10/18/2022SE |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 08/13/2021SE |
| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 03/13/2020SE |
More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K110435 | Easygluco Plus Blood Glucose Monitoring SystemNBW · Special | 09/21/2011SE |
| K082201 | G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024ANBW · Traditional | 02/20/2009SE |
| K051651 | G4, Model IGM-0004NBW · Traditional | 04/14/2006SE |
| K870687 | Coagulation Control, Level IIIJPA · Traditional | 04/20/1987SE |
| K870686 | Coagulation Control, Level IIJPA · Traditional | 04/20/1987SE |
| K870685 | Coagulation Control, Level IJPA · Traditional | 04/20/1987SE |
| K870596 | Prothrombin Time TestGJS · Traditional | 04/20/1987SE |
| K871283 | Cyanmethemoglobin StandardKRZ · Traditional | 04/15/1987SE |
| K870738 | U.S. Diagnostics Liquid CK Isoenzyme ControlJJT · Traditional | 04/13/1987SE |
| K870737 | U.S. Diagnostics Liquid LD Isoenzyme ControlJJT · Traditional | 04/13/1987SE |
Questions and answers
When was Easygluco, Model IGM-0002 G2 cleared by the FDA?
Easygluco, Model IGM-0002 G2 (K061431) received a 510(k) decision of Substantially Equivalent on January 12, 2007, 233 days after the submission was received.
What is the product code of K061431?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.