CARDIAC STATUS CONTROLS/TROPONIN I— 510(k) K972687

Substantially Equivalent

Spectral Diagnostics, Inc.

FDA 510(k) clearance K972687 for CARDIAC STATUS CONTROLS/TROPONIN I, Substantially Equivalent on 1997-07-28. Applicant: Spectral Diagnostics, Inc..

Clearance details

Applicant: Spectral Diagnostics, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1997-07-17
Decision date: 1997-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.