Nano-Check Ami 2 in 1 Cardiac Marker, CTNL and Myoglobin
FDA 510(k) K102441 · Nano-Ditech Corporation
510(k) numberK102441
Submission
- Device name
- Nano-Check Ami 2 in 1 Cardiac Marker, CTNL and Myoglobin
- Applicant
- Nano-Ditech Corporation
Cranbury, NJ, US - Received
- July 29, 2010
- Decision date
- October 20, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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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| K231187 | Nano-Check COVID-19 Antigen TestQVF · Traditional | 01/23/2024SE |
| K102131 | Nano-Check Ami Ctni Cardiac Marker TestMMI · Special | 10/20/2010SE |
| K050975 | Nano-Check Ami 3 in 1 Cardiac Disease Test for Cardiac Troponin I, Creatine Kinase MB…MMI · Traditional | 03/02/2006SE |
| K050594 | Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine…LDJ · Traditional | 05/15/2005SE |
Questions and answers
When was Nano-Check Ami 2 in 1 Cardiac Marker, CTNL and Myoglobin cleared by the FDA?
Nano-Check Ami 2 in 1 Cardiac Marker, CTNL and Myoglobin (K102441) received a 510(k) decision of Substantially Equivalent on October 20, 2010, 83 days after the submission was received.
What is the product code of K102441?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.