Liquizyme Single Solution Glucose Reag
FDA 510(k) K811592 · Amresco, Inc.
510(k) numberK811592
Submission
- Device name
- Liquizyme Single Solution Glucose Reag
- Applicant
- Amresco, Inc.
Mchenry, IL, US - Received
- June 8, 1981
- Decision date
- July 1, 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
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Questions and answers
When was Liquizyme Single Solution Glucose Reag cleared by the FDA?
Liquizyme Single Solution Glucose Reag (K811592) received a 510(k) decision of Substantially Equivalent on July 1, 1981, 23 days after the submission was received.
What is the product code of K811592?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.