K070900

Substantially Equivalent

FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT

Applicant: The Binding Site, Ltd.
Product code: DFH
Advisory panel: Immunology
Date received: 2007-04-02
Decision date: 2007-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

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