Linear Enzymatic Glucose System
FDA 510(k) K800200 · Simmler, Inc.
510(k) numberK800200
Submission
- Device name
- Linear Enzymatic Glucose System
- Applicant
- Simmler, Inc.
Mchenry, IL, US - Received
- January 30, 1980
- Decision date
- February 21, 1980
- 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 Linear Enzymatic Glucose System cleared by the FDA?
Linear Enzymatic Glucose System (K800200) received a 510(k) decision of Substantially Equivalent on February 21, 1980, 22 days after the submission was received.
What is the product code of K800200?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.