PF4 Enhanced Assay

Platelet Factor 4 Radioimmunoassay

Immucor GTI Diagnostics, Inc.

The following data is part of a premarket notification filed by Immucor Gti Diagnostics, Inc. with the FDA for Pf4 Enhanced Assay.

Pre-market Notification Details

Device IDK201570
510k NumberK201570
Device Name:PF4 Enhanced Assay
ClassificationPlatelet Factor 4 Radioimmunoassay
Applicant Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha,  WI  53186
ContactAllison Stray
CorrespondentAllison Stray
Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha,  WI  53186
Product CodeLCO  
CFR Regulation Number864.7695 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-11
Decision Date2020-09-11

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