Glucocard 01-MINI Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring System
FDA 510(k) K142035 · Arkray Factory, Inc.
510(k) numberK142035
Submission
- Device name
- Glucocard 01-MINI Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring System
- Applicant
- Arkray Factory, Inc.
Edina, MN, US - Received
- July 28, 2014
- Decision date
- September 5, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
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| K170064 | GLUCOCARD W Blood Glucose Monitoring SystemNBW · Traditional | 08/16/2017SE |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80PDJ · Traditional | 06/29/2017SE |
| K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring…CGA · Special | 09/17/2014SE |
| K124021 | Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose…CGA · Traditional | 06/30/2014SE |
Questions and answers
When was Glucocard 01-MINI Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring System cleared by the FDA?
Glucocard 01-MINI Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring System (K142035) received a 510(k) decision of Substantially Equivalent on September 5, 2014, 39 days after the submission was received.
What is the product code of K142035?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.