K003094

Substantially Equivalent

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

Applicant: Qualigen, Inc.
Product code: LTJ
Advisory panel: Immunology
Date received: 2000-10-03
Decision date: 2000-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

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