PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
FDA 510(k) clearance K060768 · decided 2006-04-21
Clearance details
- K-number
- K060768
- Device name
- PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
- Applicant
- Abbott Diabetes Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-22
- Decision date
- 2006-04-21
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- JIN
- Device class
- 1
- Regulation number
- 862.1435
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 recall (Z-1558-2020) | Abbott Diabetes Care, Inc. | 2020-02-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S057) | Abbott Diabetes Care, Inc. | 2025-07-11 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S060) | Abbott Diabetes Care, Inc. | 2025-07-11 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S056) | Abbott Diabetes Care, Inc. | 2024-04-05 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S059) | Abbott Diabetes Care, Inc. | 2023-11-21 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S055) | Abbott Diabetes Care, Inc. | 2023-11-21 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S058) | Abbott Diabetes Care, Inc. | 2023-06-30 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S053) | Abbott Diabetes Care, Inc. | 2023-06-30 |
| FreeStyle Libre 14-day Flash Glucose Monitoring System (P160030/S052) | Abbott Diabetes Care, Inc. | 2023-01-17 |