One Drop Blood Glucose Monitoring System
510(k)K161834Clinical ChemistryNBW
AgaMatrix, Inc. is listed for One Drop Blood Glucose Monitoring System (K161834). The FDA list gives November 30, 2016 as the date of the final decision. The lead panel is Clinical Chemistry, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is NBW. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161834
- Date of final decision
- November 30, 2016
- Company on the FDA list
- AgaMatrix, Inc.
- Lead panel
- Clinical Chemistry
- Primary product code
- NBW
- openFDA device name for the code
- System, Test, Blood Glucose, Over The Counter
- Device class
- 2
- Regulation number
- 862.1345
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary