Selfcheck Gluco
FDA 510(k) K061528 · Card Guard Scientific Survival , Ltd.
510(k) numberK061528
Submission
- Device name
- Selfcheck Gluco
- Applicant
- Card Guard Scientific Survival , Ltd.
Rehovot, IL - Received
- June 2, 2006
- Decision date
- September 22, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Selfcheck Gluco cleared by the FDA?
Selfcheck Gluco (K061528) received a 510(k) decision of Substantially Equivalent on September 22, 2006, 112 days after the submission was received.
What is the product code of K061528?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.