Glucose Oxidase/Peroxidase Test
FDA 510(k) K831411 · King Diagnostics, Inc.
510(k) numberK831411
Submission
- Device name
- Glucose Oxidase/Peroxidase Test
- Applicant
- King Diagnostics, Inc.
Mchenry, IL, US - Received
- May 2, 1983
- Decision date
- July 6, 1983
- 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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Questions and answers
When was Glucose Oxidase/Peroxidase Test cleared by the FDA?
Glucose Oxidase/Peroxidase Test (K831411) received a 510(k) decision of Substantially Equivalent on July 6, 1983, 65 days after the submission was received.
What is the product code of K831411?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.