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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platelet Factor 4 Radioimmunoassay
510(k) Number K201570
Device Name PF4 Enhanced assay
Applicant
Immucor Gti Diagnostics, Inc.
20925 Crossroads Cir.
Waukesha,  WI  53186
Applicant Contact Allison Stray
Correspondent
Immucor Gti Diagnostics, Inc.
20925 Crossroads Cir.
Waukesha,  WI  53186
Correspondent Contact Allison Stray
Regulation Number864.7695
Classification Product Code
LCO  
Date Received06/11/2020
Decision Date 09/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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