Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring System
FDA 510(k) K133260 · Tianjin Empecs Medical Device Co., Ltd.
510(k) numberK133260
Submission
- Device name
- Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring System
- Applicant
- Tianjin Empecs Medical Device Co., Ltd.
Fullerton, CA, US - Received
- October 23, 2013
- Decision date
- June 27, 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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|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| 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 |
More from Ascensia Diabetes Care
| 510(k) | Device | Decision |
|---|---|---|
| K162564 | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring…NBW · Traditional | 06/07/2017SE |
| K152534 | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose…NBW · Special | 03/21/2017SE |
| K111456 | Medisign Blood Glucose Monitoring SystemNBW · Traditional | 02/28/2012SE |
Questions and answers
When was Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring System cleared by the FDA?
Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring System (K133260) received a 510(k) decision of Substantially Equivalent on June 27, 2014, 247 days after the submission was received.
What is the product code of K133260?
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.