Omnis Health Embrace Glucose Control Solution
FDA 510(k) K091914 · Bionostics, Inc.
510(k) numberK091914
Submission
- Device name
- Omnis Health Embrace Glucose Control Solution
- Applicant
- Bionostics, Inc.
Devens, MA, US - Received
- June 30, 2009
- Decision date
- November 6, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Omnis Health Embrace Glucose Control Solution cleared by the FDA?
Omnis Health Embrace Glucose Control Solution (K091914) received a 510(k) decision of Substantially Equivalent on November 6, 2009, 129 days after the submission was received.
What is the product code of K091914?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.