510(k) K182521— FastPack IP Sex Hormone Binding Globulin Immunoassay

Substantially Equivalent

Qualigen, Inc.

Clearance details

Applicant: Qualigen, Inc.
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 2018-09-13
Decision date: 2019-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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