Troponin (Trop) Method
FDA 510(k) K973650 · Dade Chemistry Systems, Inc.
510(k) numberK973650
Submission
- Device name
- Troponin (Trop) Method
- Applicant
- Dade Chemistry Systems, Inc.
Glasgow, DE, US - Received
- September 25, 1997
- Decision date
- October 20, 1997
- 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 |
|---|---|---|
| K973100 | Prostate Specific Antigen (Psa) CalibratorJIT · Traditional | 09/29/1997SE |
| K973099 | Prostate Specific Antigen ControlJJX · Traditional | 09/29/1997SE |
| K973101 | Prostate Specific Antigen MethodLTJ · Traditional | 09/18/1997SE |
| K971141 | FT4 Method for the Dimension RXL Clinical Chemistry SystemCEC · Traditional | 04/28/1997SE |
| K970387 | Human Chorionic Gonadotropin MethodDHA · Traditional | 03/10/1997SE |
| K970393 | Thyroid Stimulating Hormone MethodJLW · Traditional | 03/03/1997SE |
| K970336 | MMB CalibratorJIT · Traditional | 03/03/1997SE |
| K970396 | Human Chorionic Gonadotropin CalibratorJIW · Traditional | 02/20/1997SE |
| K970389 | Thyroid CalibratorJIT · Traditional | 02/18/1997SE |
| K970343 | MMB MethodJHY · Traditional | 02/14/1997SE |
Questions and answers
When was Troponin (Trop) Method cleared by the FDA?
Troponin (Trop) Method (K973650) received a 510(k) decision of Substantially Equivalent on October 20, 1997, 25 days after the submission was received.
What is the product code of K973650?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.