BIODEX ACT-O-KIT TSH-RIA-— 510(k) K840088

Substantially Equivalent

Biodan Medical Systems, Ltd.

FDA 510(k) clearance K840088 for BIODEX ACT-O-KIT TSH-RIA-, Substantially Equivalent on 1984-05-07. Applicant: Biodan Medical Systems, Ltd..

Clearance details

Applicant: Biodan Medical Systems, Ltd.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1984-01-10
Decision date: 1984-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

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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.