Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose Control Solutions (Low and High)
FDA 510(k) K032657 · Home Diagnostics, Inc.
510(k) numberK032657
Submission
- Device name
- Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose Control Solutions (Low and High)
- Applicant
- Home Diagnostics, Inc.
Fort Lauderdale, FL, US - Received
- August 28, 2003
- Decision date
- March 24, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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More from Ascensia Diabetes Care
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|---|---|---|
| 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 |
| K060793 | Element Blood Glucose Test SystemNBW · Special | 07/25/2006SE |
| 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 |
| 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 Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose Control Solutions (Low and High) cleared by the FDA?
Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose Control Solutions (Low and High) (K032657) received a 510(k) decision of Substantially Equivalent on March 24, 2004, 209 days after the submission was received.
What is the product code of K032657?
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.