DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE— 510(k) K060090

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K060090 for DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE, Substantially Equivalent on 2006-02-27. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2006-01-12
Decision date: 2006-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.