FASTPACK TOTAL PSA METHOD VERIFICATION KIT— 510(k) K062957

Substantially Equivalent

Qualigen, Inc.

FDA 510(k) clearance K062957 for FASTPACK TOTAL PSA METHOD VERIFICATION KIT, Substantially Equivalent on 2007-04-02. Applicant: Qualigen, Inc..

Clearance details

Applicant: Qualigen, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2006-09-29
Decision date: 2007-04-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Carlsbad, CA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.