DeviceClearance

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay— 510(k) K190675

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K190675 for Dimension EXL High-Sensitivity Troponin I (TNIH) Assay, Substantially Equivalent on 2019-05-17. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code MMI
Device class
Class 2
Regulation
21 CFR 862.1215
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newark, DE, US
Download summary PDFView 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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K190675

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190675.

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