Cardiac Status Ck-Mb/Myoglobin/Troponin I Rapid Test
FDA 510(k) K981882 · Princeton BioMeditech Corp.
510(k) numberK981882
Submission
- Device name
- Cardiac Status Ck-Mb/Myoglobin/Troponin I Rapid Test
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- May 28, 1998
- Decision date
- July 6, 1998
- 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
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| 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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Questions and answers
When was Cardiac Status Ck-Mb/Myoglobin/Troponin I Rapid Test cleared by the FDA?
Cardiac Status Ck-Mb/Myoglobin/Troponin I Rapid Test (K981882) received a 510(k) decision of Substantially Equivalent on July 6, 1998, 39 days after the submission was received.
What is the product code of K981882?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.