Germco Test R Glucose Test Kit
FDA 510(k) K810567 · Fermco Biochemics, Inc.
510(k) numberK810567
Submission
- Device name
- Germco Test R Glucose Test Kit
- Applicant
- Fermco Biochemics, Inc.
Mchenry, IL, US - Received
- March 3, 1981
- Decision date
- March 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K843832 | Triglycerides Reagent SystemCDT · Traditional | 11/27/1984SE |
| K823106 | Rermco Test Chloride ReagentJFS · Traditional | 11/16/1982SE |
| K822118 | Fermcotest Creatinine Test ReagentCGX · Traditional | 09/30/1982SE |
| K822117 | Fermcotest CO2 ReagnetJFL · Traditional | 09/30/1982SE |
| K791066 | Glucose God-Pap Trinder Method Test KitCGA · Traditional | 09/04/1979SE |
| K791018 | Fermcotest R Bun Rate Reagent Test KitCDS · Traditional | 07/17/1979SE |
| K781945 | Glucose Oxidase ReagentCGA · Traditional | 01/17/1979SE |
Questions and answers
When was Germco Test R Glucose Test Kit cleared by the FDA?
Germco Test R Glucose Test Kit (K810567) received a 510(k) decision of Substantially Equivalent on March 13, 1981, 10 days after the submission was received.
What is the product code of K810567?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.