MMIClass II

Immunoassay Method, Troponin Subunit

21 CFR 862.1215 / Clinical Chemistry

MMI is the FDA product code for Immunoassay Method, Troponin Subunit, a class II device type, regulated under 21 CFR 862.1215. As of 2026-09-10, FDA records hold 95 510(k) clearances under this code, the most recent dated 2026-06-11, and 56 recalls.

Classification record

Product code: MMI
Device name: Immunoassay Method, Troponin Subunit
Regulation: 21 CFR 862.1215
Device class: Class II
Review panel: Clinical Chemistry
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 95
Ingested recalls: 56

Clearances, product code MMI

By decision year

95 clearances under product code MMI with a decision year between 1994 and 2026, 1998 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code MMI by decision year
Year	Clearances
1994	1
1995	2
1996	5
1997	7
1998	9
1999	6
2000	1
2001	6
2002	6
2003	7
2004	6
2005	5
2006	4
2007	3
2008	1
2009	1
2010	2
2011	1
2013	2
2017	1
2018	4
2019	3
2021	1
2022	1
2023	3
2024	2
2025	4
2026	1

Applicants with the most clearances

Product code MMI

Applicants holding the most 510(k) clearances under product code MMI
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	25
Boehringer Mannheim Corp.	6
Ortho-Clinical Diagnostics, Inc.	6
Roche Diagnostics GmbH	6
Abbott Medical	5
Spectral Diagnostics, Inc.	4
Abbott Laboratories Diagnostics Division	3
Bayer Corp.	3
First Medical, Inc.	3
Nano-Ditech Corporation	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order