SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.— 510(k) K861920

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K861920 for SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO., Substantially Equivalent on 1986-06-16. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1986-05-19
Decision date: 1986-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, 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.