AXSYM TOXO IGM
FDA 510(k) clearance K954576 · decided 1996-08-23
Clearance details
- K-number
- K954576
- Device name
- AXSYM TOXO IGM
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1995-10-02
- Decision date
- 1996-08-23
- Days to decision
- 326 days
- Clearance type
- Traditional
- Product code
- LGD
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Buffalo, NY, US
- Third-party review
- No
- Expedited review
- No
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| LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (K132234) | DiaSorin, Inc. | 2013-08-28 |
| LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (K131441) | DiaSorin, Inc. | 2013-08-09 |
| VIDAS TOXO IGG AVIDITY (K101946) | bioMerieux, Inc. | 2011-05-18 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AxSYM Toxo IgM Reagent Pack; list 04B25; 100 test pack; in-vitro diagnostic; Abbott Labora recall (Z-1031-2007) | Abbott Laboratories | 2007-07-11 |
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 |