Element Blood Glucose Monitoring System
FDA 510(k) K113670 · Infopia Co, Ltd.
510(k) numberK113670
Submission
- Device name
- Element Blood Glucose Monitoring System
- Applicant
- Infopia Co, Ltd.
Fullerton, CA, US - Received
- December 13, 2011
- Decision date
- May 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Element Blood Glucose Monitoring System cleared by the FDA?
Element Blood Glucose Monitoring System (K113670) received a 510(k) decision of Substantially Equivalent on May 8, 2012, 147 days after the submission was received.
What is the product code of K113670?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.