FASTPACK TSH IMMUNOASSAY— 510(k) K052301

Substantially Equivalent

Qualigen, Inc.

FDA 510(k) clearance K052301 for FASTPACK TSH IMMUNOASSAY, Substantially Equivalent on 2006-01-04. Applicant: Qualigen, Inc..

Clearance details

Applicant: Qualigen, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2005-08-22
Decision date: 2006-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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.