ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)— 510(k) K140267

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K140267 for ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM), Substantially Equivalent on 2014-03-10. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2014-02-03
Decision date: 2014-03-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tarrytown, NY, US

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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.