OPUS TROPONIN I— 510(k) K955284

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K955284 for OPUS TROPONIN I, Substantially Equivalent on 1996-01-25. Applicant: Behring Diagnostics, Inc..

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 1995-11-16
Decision date: 1996-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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Adverse events under product code MMI

product code MMI

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.