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FDA 510(k)

PF4 Enhanced assay

K-Number: K201570 · 2020-09-11

ApplicantImmucor Gti Diagnostics, Inc.
Decision Date2020-09-11
Product CodeLCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PF4 Enhanced assay is a medical device manufactured by Immucor Gti Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-09-11 under approval 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. It is manufactured by Immucor Gti Diagnostics, Inc.. The 510(k) number is K201570.

When was PF4 Enhanced assay approved by the FDA?

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

What company makes PF4 Enhanced assay?

PF4 Enhanced assay is manufactured by Immucor Gti Diagnostics, Inc..

What is the FDA product code for PF4 Enhanced assay?

The FDA product code for PF4 Enhanced assay is LCO.

Other Devices by Immucor Gti Diagnostics, Inc.

K201311PF4 IgG assay

Related Devices (Code: LCO)

K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory CO K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO K201311PF4 IgG assayImmucor Gti Diagnostics, Inc. K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.

Official Source

View on FDA Database →

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

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