K994419

Substantially Equivalent

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

Applicant: Qualisys Diagnostics, Inc.
Product code: LTJ
Advisory panel: Immunology
Date received: 1999-12-29
Decision date: 2000-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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