Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System
FDA 510(k) K000318 · Bionostics, Inc.
510(k) numberK000318
Submission
- Device name
- Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System
- Applicant
- Bionostics, Inc.
Acton, MA, US - Received
- February 1, 2000
- Decision date
- February 28, 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 the Fasttake Compact Blood Glucose Monitoring System cleared by the FDA?
Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System (K000318) received a 510(k) decision of Substantially Equivalent on February 28, 2000, 27 days after the submission was received.
What is the product code of K000318?
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.