K112343

Substantially Equivalent

TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: LIP
Advisory panel: Microbiology
Date received: 2011-08-15
Decision date: 2012-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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