Cleared Special

PF4 Enhanced assay

K201570 · Immucor Gti Diagnostics, Inc. · Hematology

Sep 2020

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K201570 is an FDA 510(k) clearance for the PF4 Enhanced assay, a Platelet Factor 4 Radioimmunoassay (Class II — Special Controls, product code LCO), submitted by Immucor Gti Diagnostics, Inc. (Waukesha, US). The FDA issued a Cleared decision on September 11, 2020, 92 days after receiving the submission on June 11, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7695.

Submission Details

510(k) Number	K201570 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2020
Decision Date	September 11, 2020
Days to Decision	92 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF