Linkdr 2.0 Diabetes Management Software
FDA 510(k) K130657 · All Medicus Co., Ltd.
510(k) numberK130657
Submission
- Device name
- Linkdr 2.0 Diabetes Management Software
- Applicant
- All Medicus Co., Ltd.
Anaheim, CA, US - Received
- March 12, 2013
- Decision date
- July 15, 2013
- 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
Other 510(k)s with product code NBW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K170241 | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring…NBW · Traditional | 10/13/2017SE |
| K083628 | Glucodr Auto SystemNBW · Traditional | 05/01/2009SE |
| K082328 | Glucodr Plus System, Model AGM-3000NBW · Traditional | 02/27/2009SE |
| K050985 | Glucodr Supersensor SystemNBW · Traditional | 10/07/2005SE |
Questions and answers
When was Linkdr 2.0 Diabetes Management Software cleared by the FDA?
Linkdr 2.0 Diabetes Management Software (K130657) received a 510(k) decision of Substantially Equivalent on July 15, 2013, 125 days after the submission was received.
What is the product code of K130657?
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.