FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM— 510(k) K971141

Substantially Equivalent

Dade Chemistry Systems, Inc.

FDA 510(k) clearance K971141 for FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM, Substantially Equivalent on 1997-04-28. Applicant: Dade Chemistry Systems, Inc..

Clearance details

Applicant: Dade Chemistry Systems, Inc.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1997-03-28
Decision date: 1997-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.