Cleared Special

PF4 IgG assay

K201311 · Immucor Gti Diagnostics, Inc. · Hematology

Jun 2020

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K201311 is an FDA 510(k) clearance for the PF4 IgG 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 June 18, 2020, 31 days after receiving the submission on May 18, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7695.

Submission Details

510(k) Number	K201311 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2020
Decision Date	June 18, 2020
Days to Decision	31 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF