EZ-BEAD TSH ENZYME IMMUNOASSAY KIT— 510(k) K903725

Name: FDA 510(k) clearance K903725
Creator: U.S. Food and Drug Administration
Published: 1990-10-26

Substantially Equivalent

Immunotech Corp.

FDA 510(k) clearance K903725 for EZ-BEAD TSH ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1990-10-26. Applicant: Immunotech Corp.. Device class: 2.

Clearance details

Applicant: Immunotech Corp.
Product code: Code JLW
Device class: Class 2
Regulation: 21 CFR 862.1690
Advisory panel: Clinical Chemistry
Date received: 1990-08-16
Decision date: 1990-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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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.