Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose Monitoring System
FDA 510(k) K124021 · Arkray Factory, Inc.
510(k) numberK124021
Submission
- Device name
- Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose Monitoring System
- Applicant
- Arkray Factory, Inc.
Edina, MN, US - Received
- December 27, 2012
- Decision date
- June 30, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring…CGA · Special | 09/17/2014SE |
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Questions and answers
When was Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose Monitoring System cleared by the FDA?
Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose Monitoring System (K124021) received a 510(k) decision of Substantially Equivalent on June 30, 2014, 550 days after the submission was received.
What is the product code of K124021?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.