RNA Medical Glucose and B-Ketone Calibration Verification Controls
FDA 510(k) K081478 · Bionostics, Inc.
510(k) numberK081478
Submission
- Device name
- RNA Medical Glucose and B-Ketone Calibration Verification Controls
- Applicant
- Bionostics, Inc.
Devens, MA, US - Received
- May 27, 2008
- Decision date
- October 6, 2008
- 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 RNA Medical Glucose and B-Ketone Calibration Verification Controls cleared by the FDA?
RNA Medical Glucose and B-Ketone Calibration Verification Controls (K081478) received a 510(k) decision of Substantially Equivalent on October 6, 2008, 132 days after the submission was received.
What is the product code of K081478?
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.