K201570

Substantially Equivalent

PF4 Enhanced assay

Applicant: Immucor Gti Diagnostics, Inc.
Product code: LCO
Advisory panel: Hematology
Date received: 2020-06-11
Decision date: 2020-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

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