Architect Stat Troponin-I Immunoassay
FDA 510(k) K041192 · Fisher Diagnostics
510(k) numberK041192
Submission
- Device name
- Architect Stat Troponin-I Immunoassay
- Applicant
- Fisher Diagnostics
Middletown, VA, US - Received
- May 6, 2004
- Decision date
- August 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMI · Traditional | Abbott Point of Care, Inc. | 06/11/2026SE |
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/29/2025SE |
| K243483 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 08/01/2025SE |
| K242870 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 06/16/2025SE |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI · Traditional | Abbott Point of Care, Inc. | 01/03/2025SE |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH)MMI · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2024SE |
| K231974 | PATHFAST®hs-cTnI-IIMMI · Traditional | Phc Corporation | 03/20/2024SE |
| K222881 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 12/18/2023SE |
| K230648 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 12/04/2023SE |
| K230994 | Alinity i STAT High Sensitivity Troponin-IMMI · Special | Abbott Laboratories Diagnostics Division | 05/04/2023SE |
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| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S…PRI · Traditional | 06/01/2017SE |
| K070640 | Architect Stat TROPONIN-1; MyoglobinMMI · Special | 09/13/2007SE |
| K052407 | Architect Anti-Tpo Immunoassay, Calibrators & ControlsJZO · Traditional | 07/18/2006SE |
| K052308 | Architect Anti-Tg Immunoassay Reagents, Calibrators, Controls and System Assay Cd-RomJZO · Traditional | 05/10/2006SE |
| K042924 | Architect Stat Myo ImmunoassayDDR · Traditional | 01/24/2005SE |
| K041596 | Architect Stat Ck-Mb ImmunoassayJHX · Traditional | 07/21/2004SE |
| K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinGKP · Traditional | 12/09/2002SE |
| K013397 | Pacific Hemostasis Reference EmulsionJIX · Traditional | 02/15/2002SE |
| K010750 | Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560GGN · Traditional | 09/07/2001SE |
| K850160 | Fisher Diagnostics Latest-Crp Test KitDCK · Traditional | 04/19/1985SE |
Questions and answers
When was Architect Stat Troponin-I Immunoassay cleared by the FDA?
Architect Stat Troponin-I Immunoassay (K041192) received a 510(k) decision of Substantially Equivalent on August 12, 2004, 98 days after the submission was received.
What is the product code of K041192?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.