AXSYM CYCLOSPORINE
FDA 510(k) clearance K040761 · decided 2004-04-30
Clearance details
- K-number
- K040761
- Device name
- AXSYM CYCLOSPORINE
- Applicant
- Abbott Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-25
- Decision date
- 2004-04-30
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- MKW
- Device class
- 2
- Regulation number
- 862.1235
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CYCLOSPORINE (K080751) | Fujirebio Diagnostics,Inc. | 2008-09-11 |
| ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (K071455) | Siemens Medical Solutions Diagnostics | 2008-09-11 |
| DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 (K081992) | Siemens Healthcare Diagnostics, Inc. | 2008-08-05 |
| DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K062236) | Dade Behring, Inc. | 2006-08-21 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (K053061) | Dade Behring, Inc. | 2006-02-06 |
| CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 (K052017) | Dade Behring, Inc. | 2005-09-01 |
| CEDIA CYCLOSPORINE PLUS ASSAY (K023208) | Microgenics Corp. | 2002-10-24 |
| CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K023065) | Dade Behring, Inc. | 2002-10-16 |
Recalls involving this device
No recalls on record reference this clearance.
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 |