DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT— 510(k) K053577

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K053577 for DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT, Substantially Equivalent on 2006-04-14. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2005-12-22
Decision date: 2006-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: P.O. Box 6101, Newark, DE, 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.