On Call Vivid Blood Glucose Monitoring Systems
FDA 510(k) K112653 · ACON Laboratories, Inc.
510(k) numberK112653
Submission
- Device name
- On Call Vivid Blood Glucose Monitoring Systems
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- September 12, 2011
- Decision date
- April 9, 2012
- 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 On Call Vivid Blood Glucose Monitoring Systems cleared by the FDA?
On Call Vivid Blood Glucose Monitoring Systems (K112653) received a 510(k) decision of Substantially Equivalent on April 9, 2012, 210 days after the submission was received.
What is the product code of K112653?
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.