Glucose Meter-Check Control Solution for Agamatrix Wavesense
FDA 510(k) K112356 · Bionostics, Inc.
510(k) numberK112356
Submission
- Device name
- Glucose Meter-Check Control Solution for Agamatrix Wavesense
- Applicant
- Bionostics, Inc.
Devens, MA, US - Received
- August 16, 2011
- Decision date
- September 19, 2011
- 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 Glucose Meter-Check Control Solution for Agamatrix Wavesense cleared by the FDA?
Glucose Meter-Check Control Solution for Agamatrix Wavesense (K112356) received a 510(k) decision of Substantially Equivalent on September 19, 2011, 34 days after the submission was received.
What is the product code of K112356?
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.