RNA GL4 Glucose Calibration Verification Control, Model RNA CVC GL4
FDA 510(k) K021624 · Bionostics, Inc.
510(k) numberK021624
Submission
- Device name
- RNA GL4 Glucose Calibration Verification Control, Model RNA CVC GL4
- Applicant
- Bionostics, Inc.
Devens, MA, US - Received
- May 16, 2002
- Decision date
- July 12, 2002
- 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 GL4 Glucose Calibration Verification Control, Model RNA CVC GL4 cleared by the FDA?
RNA GL4 Glucose Calibration Verification Control, Model RNA CVC GL4 (K021624) received a 510(k) decision of Substantially Equivalent on July 12, 2002, 57 days after the submission was received.
What is the product code of K021624?
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.