FDA 510(k)

PF4 IgG assay

K-Number: K201311 · 2020-06-18

Decision Date2020-06-18

Product CodeLCO

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

PF4 IgG assay is the device name listed in this FDA 510(k) record. The listed applicant is Immucor Gti Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K201311. The device is classified under product code LCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PF4 IgG assay?

PF4 IgG assay is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Immucor Gti Diagnostics, Inc.. The 510(k) number is K201311.

When did PF4 IgG assay receive FDA 510(k) clearance?

PF4 IgG assay received FDA 510(k) clearance on 2020-06-18, under 510(k) number K201311.

Who is the listed applicant for PF4 IgG assay?

The FDA 510(k) record lists Immucor Gti Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF4 IgG assay?

The FDA product code for PF4 IgG assay is LCO.

Other records listing Immucor Gti Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201570PF4 Enhanced assay

Related Devices (Code: LCO)

K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc.K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory CO

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.