Enzymatic Glucose Determination
FDA 510(k) K823474 · The Dow Chemical Co.
510(k) numberK823474
Submission
- Device name
- Enzymatic Glucose Determination
- Applicant
- The Dow Chemical Co.
Walker, MI, US - Received
- November 22, 1982
- Decision date
- December 30, 1982
- 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 Enzymatic Glucose Determination cleared by the FDA?
Enzymatic Glucose Determination (K823474) received a 510(k) decision of Substantially Equivalent on December 30, 1982, 38 days after the submission was received.
What is the product code of K823474?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.