BD Logic Blood Glucose Monitor and Paradigm Link Blood Glucose Monitor
FDA 510(k) K041478 · Becton Dickinson
510(k) numberK041478
Submission
- Device name
- BD Logic Blood Glucose Monitor and Paradigm Link Blood Glucose Monitor
- Applicant
- Becton Dickinson
Franklin Lakes, NJ, US - Received
- June 3, 2004
- Decision date
- October 28, 2004
- 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 BD Logic Blood Glucose Monitor and Paradigm Link Blood Glucose Monitor cleared by the FDA?
BD Logic Blood Glucose Monitor and Paradigm Link Blood Glucose Monitor (K041478) received a 510(k) decision of Substantially Equivalent on October 28, 2004, 147 days after the submission was received.
What is the product code of K041478?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.