PF4 Enhanced assay— 510(k) K201570

Name: FDA 510(k) clearance K201570
Creator: U.S. Food and Drug Administration
Published: 2020-09-11

Substantially Equivalent

Immucor Gti Diagnostics, Inc.

FDA 510(k) clearance K201570 for PF4 Enhanced assay, Substantially Equivalent on 2020-09-11. Applicant: Immucor Gti Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Immucor Gti Diagnostics, Inc.
Product code: Code LCO
Device class: Class 2
Regulation: 21 CFR 864.7695
Advisory panel: Hematology
Date received: 2020-06-11
Decision date: 2020-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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