Biocheck Human Cardiac Troponin-I Immunoassay Test Kit
FDA 510(k) K013062 · Biocheck, Inc.
510(k) numberK013062
Submission
- Device name
- Biocheck Human Cardiac Troponin-I Immunoassay Test Kit
- Applicant
- Biocheck, Inc.
Northridge, CA, US - Received
- September 12, 2001
- Decision date
- January 8, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|
| K041619 | Bio Check Whole Blood/Plasma/Sermon Model #801116MMI · Traditional | 12/17/2004SE |
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| K022660 | Biocheck Myoglobin Elisa, Model BC-1117DRR · Traditional | 12/19/2002SE |
| K003851 | Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model BC-1119DCK · Traditional | 07/20/2001SE |
| K002294 | Biocheck Testosterone Eia, Model BC-1115CDZ · Traditional | 10/02/2000SE |
| K001022 | Biocheck, Inc. B-2 Microglobin Enzyme Immunoasay Test Kit, Model BC-1061JZG · Traditional | 09/26/2000SE |
| K992517 | Biocheck Ferritin Elisa Model BC-1025DBF · Traditional | 09/24/1999SE |
| K992528 | Biocheck Ige Elisa, Model BC-1035DGC · Traditional | 09/21/1999SE |
| K991741 | Biocheck HCG Enzyme Immunoassay Test Kit, Model BC-1027JHI · Traditional | 07/22/1999SE |
| K991146 | TSH Enzyme Immunoassay Test Kit, Model #BC-1001JLW · Traditional | 06/22/1999SE |
Questions and answers
When was Biocheck Human Cardiac Troponin-I Immunoassay Test Kit cleared by the FDA?
Biocheck Human Cardiac Troponin-I Immunoassay Test Kit (K013062) received a 510(k) decision of Substantially Equivalent on January 8, 2002, 118 days after the submission was received.
What is the product code of K013062?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.