CARDIOQUANT TROPONIN I TEST— 510(k) K992127

Name: FDA 510(k) clearance K992127
Creator: U.S. Food and Drug Administration
Published: 1999-10-04

Substantially Equivalent

Spectral Diagnostics, Inc.

FDA 510(k) clearance K992127 for CARDIOQUANT TROPONIN I TEST, Substantially Equivalent on 1999-10-04. Applicant: Spectral Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Spectral Diagnostics, Inc.
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1999-06-23
Decision date: 1999-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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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.