Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System
FDA 510(k) K130094 · Abbott Diabetes Care
510(k) numberK130094
Submission
- Device name
- Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System
- Applicant
- Abbott Diabetes Care
Alameda, CA, US - Received
- January 10, 2013
- Decision date
- June 27, 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
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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 |
| 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 |
|---|---|---|
| K233861 | Libre Rio Continuous Glucose Monitoring SystemSBH · Traditional | 06/07/2024SE |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…QBJ · Traditional | 04/23/2024SE |
| K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…QBJ · Traditional | 04/13/2023SE |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose…QBJ · Traditional | 03/03/2023SE |
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 SystemQLG · Traditional | 02/21/2023SE |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG · Traditional | 05/26/2022SE |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG · Traditional | 05/26/2022SE |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG · Traditional | 11/22/2021SE |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring SystemQLG · Traditional | 08/11/2021SE |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG · Traditional | 07/30/2021SE |
Questions and answers
When was Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System cleared by the FDA?
Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System (K130094) received a 510(k) decision of Substantially Equivalent on June 27, 2013, 168 days after the submission was received.
What is the product code of K130094?
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.