Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter Caresens N Blood Glucose Test Strip Ca
FDA 510(k) K120351 · I-Sens, Inc.
510(k) numberK120351
Submission
- Device name
- Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter Caresens N Blood Glucose Test Strip Ca
- Applicant
- I-Sens, Inc.
Seoul, KR - Received
- February 6, 2012
- Decision date
- May 3, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| 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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| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose…NBW · Special | 10/05/2021SE |
| K201551 | KetoSens BT Blood B-Ketone Monitoring SystemJIN · Special | 09/09/2020SE |
| K192859 | CareSens S Clear BT Blood Glucose Monitoring SystemNBW · Special | 01/24/2020SE |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring SystemNBW · Special | 01/17/2020SE |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring SystemNBW · Special | 12/13/2019SE |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood…NBW · Special | 11/01/2018SE |
| K180866 | CareSens S Fit Blood Glucose Monitoring SystemNBW · Traditional | 08/31/2018SE |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN · Traditional | 04/13/2018SE |
Questions and answers
When was Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter Caresens N Blood Glucose Test Strip Ca cleared by the FDA?
Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter Caresens N Blood Glucose Test Strip Ca (K120351) received a 510(k) decision of Substantially Equivalent on May 3, 2012, 87 days after the submission was received.
What is the product code of K120351?
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.