Bacton Dickinson Latitude Blood Glucose Monitoring System
FDA 510(k) K022580 · Becton, Dickinson & CO
510(k) numberK022580
Submission
- Device name
- Bacton Dickinson Latitude Blood Glucose Monitoring System
- Applicant
- Becton, Dickinson & CO
Franklin Lakes, NJ, US - Received
- August 5, 2002
- Decision date
- October 9, 2002
- 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 Bacton Dickinson Latitude Blood Glucose Monitoring System cleared by the FDA?
Bacton Dickinson Latitude Blood Glucose Monitoring System (K022580) received a 510(k) decision of Substantially Equivalent on October 9, 2002, 65 days after the submission was received.
What is the product code of K022580?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.