← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MMI — Immunoassay Method, Troponin Subunit

DEVICE CLASS
Class II
REGULATION
21 CFR 862.1215
MEDICAL SPECIALTY
Clinical Chemistry
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K253051Abbott Point of Care, Inc. · 510k2026-06-11
K252393Ortho-Clinical Diagnostics, Inc. · 510k2025-10-29
K243483Beckman Coulter, Inc. · 510k2025-08-01
K242870Beckman Coulter, Inc. · 510k2025-06-16
K240984Abbott Point of Care, Inc. · 510k2025-01-03

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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