K090901

Substantially Equivalent

ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8

Applicant: Osmetech Molecular Diagnostics
Product code: NUA
Advisory panel: Immunology
Date received: 2009-04-01
Decision date: 2009-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pasadena, CA, US

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