Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip Systems
FDA 510(k) K002540 · Bionostics, Inc.
510(k) numberK002540
Submission
- Device name
- Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip Systems
- Applicant
- Bionostics, Inc.
Acton, MA, US - Received
- August 16, 2000
- Decision date
- September 18, 2000
- 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 Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip Systems cleared by the FDA?
Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip Systems (K002540) received a 510(k) decision of Substantially Equivalent on September 18, 2000, 33 days after the submission was received.
What is the product code of K002540?
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.