FDA 510(k)

PF4 Enhanced assay

K-Number: K201570 · 2020-09-11

Decision Date2020-09-11

Product CodeLCO

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

PF4 Enhanced 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 2020-09-11 under 510(k) number K201570. 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 Enhanced assay?

PF4 Enhanced assay is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Immucor Gti Diagnostics, Inc.. The 510(k) number is K201570.

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

PF4 Enhanced assay received FDA 510(k) clearance on 2020-09-11, under 510(k) number K201570.

Who is the listed applicant for PF4 Enhanced 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 Enhanced assay?

The FDA product code for PF4 Enhanced 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.

K201311PF4 IgG assay

Related Devices (Code: LCO)

K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.K201311PF4 IgG 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.