ABBOTT ARCHITECT B12
FDA 510(k) clearance K984108 · decided 1999-02-03
Clearance details
- K-number
- K984108
- Device name
- ABBOTT ARCHITECT B12
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-11-17
- Decision date
- 1999-02-03
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LIG
- Device class
- 2
- Regulation number
- 862.1810
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitr recall (Z-0860-06) | Abbott Laboratories MPG | 2006-05-11 |
| B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, recall (Z-0435-05) | Abbott Laboratories, Inc | 2005-01-26 |
| ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott recall (Z-1452-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-09-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |