510(k) K994419— FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

Substantially Equivalent

Qualisys Diagnostics, Inc.

Clearance details

Applicant: Qualisys Diagnostics, Inc.
Product code: 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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