Prestige Iq Blood Glucose Test System, Model 507400, 537600, 550600, 561700, 563700
FDA 510(k) K010403 · Home Diagnostics, Inc.
510(k) numberK010403
Submission
- Device name
- Prestige Iq Blood Glucose Test System, Model 507400, 537600, 550600, 561700, 563700
- Applicant
- Home Diagnostics, Inc.
Fort Lauderdale, FL, US - Received
- February 12, 2001
- Decision date
- March 26, 2001
- 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
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 |
|---|---|---|
| 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 |
| 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 |
Questions and answers
When was Prestige Iq Blood Glucose Test System, Model 507400, 537600, 550600, 561700, 563700 cleared by the FDA?
Prestige Iq Blood Glucose Test System, Model 507400, 537600, 550600, 561700, 563700 (K010403) received a 510(k) decision of Substantially Equivalent on March 26, 2001, 42 days after the submission was received.
What is the product code of K010403?
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.