Ascensia Breeze Blood Glucose Meter
FDA 510(k) K024062 · Bayer Corp.
510(k) numberK024062
Submission
- Device name
- Ascensia Breeze Blood Glucose Meter
- Applicant
- Bayer Corp.
Elkhart, IN, US - Received
- December 9, 2002
- Decision date
- March 3, 2003
- 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 Ascensia Breeze Blood Glucose Meter cleared by the FDA?
Ascensia Breeze Blood Glucose Meter (K024062) received a 510(k) decision of Substantially Equivalent on March 3, 2003, 84 days after the submission was received.
What is the product code of K024062?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.