Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac Troponin-I Calibrators
FDA 510(k) K951890 · Dade Intl., Inc.
510(k) numberK951890
Submission
- Device name
- Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac Troponin-I Calibrators
- Applicant
- Dade Intl., Inc.
Miami, FL, US - Received
- April 24, 1995
- Decision date
- July 13, 1995
- 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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| K973974 | Dade Tru-Liquid Cardiac ControlJJT · Traditional | 11/06/1997SE |
| K973668 | Cardiac Troponin-I (Trop) CalibratorJIT · Traditional | 10/20/1997SE |
| K972524 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 09/08/1997SE |
| K972782 | Dade Stratus Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 08/15/1997SE |
| K972287 | Dade Tru-Liquid Bilirubin ControlJJX · Traditional | 07/07/1997SE |
| K964660 | Paramax Cholesterol ReagentCHH · Traditional | 06/04/1997SE |
| K970676 | Dried Gram-Negative Mic/Combo PanelsJWY · Traditional | 05/02/1997SE |
| K964715 | Paramax Salicylate ReagentDKJ · Traditional | 04/25/1997SE |
Questions and answers
When was Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac Troponin-I Calibrators cleared by the FDA?
Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac Troponin-I Calibrators (K951890) received a 510(k) decision of Substantially Equivalent on July 13, 1995, 80 days after the submission was received.
What is the product code of K951890?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.