Element Blood Glucose Test System
FDA 510(k) K060793 · Home Diagnostics, Inc.
510(k) numberK060793
Submission
- Device name
- Element Blood Glucose Test System
- Applicant
- Home Diagnostics, Inc.
Fort Lauderdale, FL, US - Received
- March 23, 2006
- Decision date
- July 25, 2006
- 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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| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
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| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
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| 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 |
|---|---|---|
| K090495 | Truebalance Blood Glucose SystemNBW · Special | 03/27/2009SE |
| K080641 | Trueresult Blood Glucose System E4H01-81NBW · Traditional | 08/19/2008SE |
| K080710 | TRUE2GO Blood Glucose System, Model F4H01-81NBW · Traditional | 08/13/2008SE |
| K070593 | Trackrecord Data Management SoftwareNBW · Traditional | 05/07/2007SE |
| K051147 | Sidekick Blood Glucose Test SystemNBW · Special | 07/12/2005SE |
| K042080 | Trackease Smart System Blood Glucose SystemJJX · Special | 08/19/2004SE |
| K040670 | Modification to Truetrack Smart System Blood Glucose Meter, Test Strips and Glucose…NBW · Special | 03/25/2004SE |
| K032657 | Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose…NBW · Traditional | 03/24/2004SE |
| K030703 | Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose…NBW · Traditional | 07/11/2003SE |
| K010403 | Prestige Iq Blood Glucose Test System, Model 507400, 537600, 550600, 561700, 563700NBW · Special | 03/26/2001SE |
Questions and answers
When was Element Blood Glucose Test System cleared by the FDA?
Element Blood Glucose Test System (K060793) received a 510(k) decision of Substantially Equivalent on July 25, 2006, 124 days after the submission was received.
What is the product code of K060793?
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.