ABBOTT ARCHITECT HAVAB-M
FDA 510(k) clearance K063329 · decided 2007-04-16
Clearance details
- K-number
- K063329
- Device name
- ABBOTT ARCHITECT HAVAB-M
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2006-11-03
- Decision date
- 2007-04-16
- Days to decision
- 164 days
- Clearance type
- Abbreviated
- Product code
- LOL
- Device class
- 2
- Regulation number
- 866.3310
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for t recall (Z-2413-2011) | Abbott Laboratories | 2011-06-06 |
| ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qual recall (Z-1596-2010) | Abbott Diagnostics International, Ltd. | 2010-05-19 |
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 |