K122722

Substantially Equivalent

COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160

Applicant: Roche Diagnostics
Product code: DFC
Advisory panel: Immunology
Date received: 2012-09-05
Decision date: 2012-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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