Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose Test System
FDA 510(k) K032819 · Bionostics, Inc.
510(k) numberK032819
Submission
- Device name
- Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose Test System
- Applicant
- Bionostics, Inc.
Devens, MA, US - Received
- September 10, 2003
- Decision date
- October 20, 2003
- 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 Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose Test System cleared by the FDA?
Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose Test System (K032819) received a 510(k) decision of Substantially Equivalent on October 20, 2003, 40 days after the submission was received.
What is the product code of K032819?
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.