Vitros Immunodiagnostic Products Troponin I Reagent Pack
FDA 510(k) K992366 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK992366
Submission
- Device name
- Vitros Immunodiagnostic Products Troponin I Reagent Pack
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- July 15, 1999
- Decision date
- October 8, 1999
- 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 |
More from Abbott Laboratories Diagnostics Division
| 510(k) | Device | Decision |
|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | 10/29/2025SE |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional | 08/28/2024SE |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | 09/05/2023SE |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent PackDHX · Traditional | 08/23/2023SE |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional | 08/09/2023SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
| K213626 | Vitros AfpLOJ · Traditional | 06/15/2022SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional | 10/04/2021SE |
Questions and answers
When was Vitros Immunodiagnostic Products Troponin I Reagent Pack cleared by the FDA?
Vitros Immunodiagnostic Products Troponin I Reagent Pack (K992366) received a 510(k) decision of Substantially Equivalent on October 8, 1999, 85 days after the submission was received.
What is the product code of K992366?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.