PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
FDA 510(k) clearance K051213 · decided 2005-05-27
Clearance details
- K-number
- K051213
- Device name
- PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
- Applicant
- Abbott Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-12
- Decision date
- 2005-05-27
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- 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 |
|---|---|---|
| Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; MediSense Optium Blood G recall (Z-0996-2011) | Abbott Diabetes Care, Inc. | 2011-02-09 |
| Abbott Diabetes Care, Optium Blood Glucose Test Strips; recall (Z-0997-2011) | Abbott Diabetes Care, Inc. | 2011-02-09 |
| Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips; Precision Xtra Blood Gluco recall (Z-0999-2011) | Abbott Diabetes Care, Inc. | 2011-02-09 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT AUSAB; Alinity i Anti-HBs (P050051/S061) | Abbott Laboratories, Inc. | 2025-04-03 |
| ARCHITECT AUSAB/Alinity i Anti-HBs (P050051/S060) | Abbott Laboratories, Inc. | 2024-05-23 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S059) | Abbott Laboratories, Inc. | 2024-03-22 |
| ARCHITECT AUSAB (P050051/S050) | Abbott Laboratories, Inc. | 2024-01-19 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S058) | Abbott Laboratories, Inc. | 2023-12-14 |
| ARCHITECT AUSAB, Alinity i Anti-HBs (P050051/S057) | Abbott Laboratories, Inc. | 2023-12-07 |
| Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent (P050051/S056) | Abbott Laboratories, Inc. | 2023-11-06 |
| Alinity i Anti-HBs Reagent Kit (2x100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent K (P050051/S055) | Abbott Laboratories, Inc. | 2023-11-03 |