FASTPACK TESTO IMMUNOASSAY— 510(k) K101388

Substantially Equivalent

Qualigen, Inc.

FDA 510(k) clearance K101388 for FASTPACK TESTO IMMUNOASSAY, Substantially Equivalent on 2011-02-18. Applicant: Qualigen, Inc..

Clearance details

Applicant: Qualigen, Inc.
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 2010-05-17
Decision date: 2011-02-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

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