Access hs Tnl— 510(k) K172783

Clearance details

Applicant

Beckman Coulter, Inc.

Product code

Code MMI

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

2017-09-15

Decision date

2018-06-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chaska, MN, US

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Injury

172

Malfunction

3,762

Total

3,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0727-2025 — Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.Class II·Ongoing·Beckman Coulter, Inc.·20241118
• Z-0032-2022 — Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACKClass II·Ongoing·Beckman Coulter Inc.·20210809

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172783.