FreeStyle Lite Blood Glucose Monitoring System
FDA 510(k) K150332 · Abbott Laboratories
510(k) numberK150332
Submission
- Device name
- FreeStyle Lite Blood Glucose Monitoring System
- Applicant
- Abbott Laboratories
Alameda, CA, US - Received
- February 10, 2015
- Decision date
- June 5, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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Questions and answers
When was FreeStyle Lite Blood Glucose Monitoring System cleared by the FDA?
FreeStyle Lite Blood Glucose Monitoring System (K150332) received a 510(k) decision of Substantially Equivalent on June 5, 2015, 115 days after the submission was received.
What is the product code of K150332?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.