510(k) K121790
- Device
- ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K121790
- Product code
- MMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-09-25
- Date received
- 2012-06-18
- Regulation
- 862.1215
- Classification name
- Immunoassay Method, Troponin Subunit
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KERRIE OETTER
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 3013982035
- 3005094123
- 3006198300
- 2246703
- 3005360469
- 1181121
- 9680746
- 3014353045
- 3005174594
- 3005333358
- 2432235
- 2025099
- 3022178699
- 3012963943
- 2250051
- 2060833
- 1832216
- 3004205692
- 3002809144
- 9612316
- 2020726
- 1036362
- 2517506
- 2122870
- 8031673
- 3005643513
- 1827821
- 2032682
- 3002637618
- 9610987
- 2245578
- 3002642396
- 3005984081
- 3010825766
- 3029973107
- 8020888
- 1219913
- 3005529799
- 3007111389
- 9610126
- 3003366417
- 2029372
- 3009448641
- 1319681
- 2435505
- 3003589956
- 3021841051
- 3000308930
- 3002806944
- 2032839
Source Documents#
Other 510(k) Records For Product Code MMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | 2025-10-29 |
| K243483 | Access hsTnI | Beckman Coulter, Inc. | 2025-08-01 |
| K242870 | Access hsTnI | Beckman Coulter, Inc. | 2025-06-16 |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025-01-03 |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. | 2024-07-25 |
| K231974 | PATHFAST®hs-cTnI-II | Phc Corporation | 2024-03-20 |
| K222881 | Access hsTnI | Beckman Coulter, Inc. | 2023-12-18 |
| K230648 | Access hsTnI | Beckman Coulter, Inc. | 2023-12-04 |
| K230994 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2023-05-04 |
| K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2022-05-19 |
| K201441 | Elecsys Troponin T Gen 5 | Roche Diagnostics | 2021-09-21 |
| K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2019-09-13 |
| K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | 2019-05-17 |
| K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | 2019-03-04 |
| K171566 | Atellica IM High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | 2018-07-19 |
Legacy Summary#
summary
FDA Review#
Decision Summary