DIMENSION VISTA FLEX REAGENT CARTRIDGES— 510(k) K061655

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K061655 for DIMENSION VISTA FLEX REAGENT CARTRIDGES, Substantially Equivalent on 2006-07-10. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code LDP
Advisory panel: Clinical Toxicology
Date received: 2006-06-13
Decision date: 2006-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Newark, DE, US

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Adverse events under product code LDP

product code LDP

Other: 1
Total: 1

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.