Diacheck Smart/Superior Blood Glucose Monitoring System
FDA 510(k) K113343 · Delbio Incorporation
510(k) numberK113343
Submission
- Device name
- Diacheck Smart/Superior Blood Glucose Monitoring System
- Applicant
- Delbio Incorporation
Taoyuan, TW - Received
- November 14, 2011
- Decision date
- February 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
More from Ascensia Diabetes Care
| 510(k) | Device | Decision |
|---|---|---|
| K133090 | Oxicare Fingertip Pulse OximeterDQA · Special | 02/28/2014SE |
| K132338 | DA01 Blood Glucose Monitoring SystemNBW · Special | 10/24/2013SE |
| K130244 | Diatrue Plus Blood Glucose Monitoring SystemNBW · Traditional | 08/23/2013SE |
| K120866 | DA01 Blood Glucose Monitoring SystemNBW · Traditional | 12/11/2012SE |
| K103329 | Diatrue Plus Blood Glucose Monitoring System; Diatrue Plus Blood Glucose Test Strip…NBW · Traditional | 03/13/2012SE |
| K100806 | Diacheck Blood Glucose Monitoring System Model: PremiumNBW · Traditional | 09/16/2011SE |
Questions and answers
When was Diacheck Smart/Superior Blood Glucose Monitoring System cleared by the FDA?
Diacheck Smart/Superior Blood Glucose Monitoring System (K113343) received a 510(k) decision of Substantially Equivalent on February 8, 2012, 86 days after the submission was received.
What is the product code of K113343?
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.