Are Keto-Mojo meters FDA certified?

  • Last updated November 20, 2017

Keto-Mojo meters sold in the U.S. are FDA-approved class II medical devices for the in vitro self-testing of glucose and ketone levels, and is suitable for testing for Type 1, Type 2, and gestational diabetes.

The meter is manufactured in an FDA-inspected and approved establishment that also conforms to ISO:9001 manufacturing practices. The meter also conforms to ISO 15197:2013 standards.

Here are more specifics, in case you’re interested:

    • Keto-Mojo TD-4279 FDA device listing number D126843
    • Keto-Check, Inc FDA registration number 10055466
    • Manufacturing facility FDA establishment registration number: 3004145393
    • All our inventory is stored in an FDA-registered warehouse in Savannah GA. Registration number 12631797414
    • Complete supply-chain custody is maintained throughout to assure you of genuine, quality products.

Learn more about the accuracy and reliability of Keto-Mojo meters.

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