Glucose Oxidase Reagent
FDA 510(k) K781945 · Fermco Biochemics, Inc.
510(k) numberK781945
Submission
- Device name
- Glucose Oxidase Reagent
- Applicant
- Fermco Biochemics, Inc.
Mchenry, IL, US - Received
- November 21, 1978
- Decision date
- January 17, 1979
- 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
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| 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 |
| K810567 | Germco Test R Glucose Test KitCGA · Traditional | 03/13/1981SE |
| K791066 | Glucose God-Pap Trinder Method Test KitCGA · Traditional | 09/04/1979SE |
| K791018 | Fermcotest R Bun Rate Reagent Test KitCDS · Traditional | 07/17/1979SE |
Questions and answers
When was Glucose Oxidase Reagent cleared by the FDA?
Glucose Oxidase Reagent (K781945) received a 510(k) decision of Substantially Equivalent on January 17, 1979, 57 days after the submission was received.
What is the product code of K781945?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.