K980716

Substantially Equivalent

ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY

Applicant: Nichols Institute Diagnostics
Product code: LTJ
Advisory panel: Immunology
Date received: 1998-01-07
Decision date: 1998-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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