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FDA 510(k)

PF4 ENHANCED SOLID PHASE ELISA

K-Number: K053559 · 2006-01-20

ApplicantGenetic Testing Institute
Decision Date2006-01-20
Product CodeLCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PF4 ENHANCED SOLID PHASE ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Testing Institute. It received FDA 510(k) clearance on 2006-01-20 under 510(k) number K053559. 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 SOLID PHASE ELISA?

PF4 ENHANCED SOLID PHASE ELISA is a medical device that received FDA 510(k) clearance on 2006-01-20. The listed applicant is Genetic Testing Institute. The 510(k) number is K053559.

When did PF4 ENHANCED SOLID PHASE ELISA receive FDA 510(k) clearance?

PF4 ENHANCED SOLID PHASE ELISA received FDA 510(k) clearance on 2006-01-20, under 510(k) number K053559.

Who is the listed applicant for PF4 ENHANCED SOLID PHASE ELISA?

The FDA 510(k) record lists Genetic Testing Institute as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF4 ENHANCED SOLID PHASE ELISA?

The FDA product code for PF4 ENHANCED SOLID PHASE ELISA is LCO.

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Other records listing Genetic Testing Institute 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.

K082205FACTOR VIII ANTIBODY SCREENK071781PF4 IGGK993553GTI-FVIII INHIBITOR ASSAYK983379GTI-PF4 ELISAK841114ALLO-TYPE HUMAN IMMUNOGLOBULIN-

Related Devices (Code: LCO)

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.

K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc.K201311PF4 IgG assayImmucor Gti Diagnostics, Inc.K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory COK153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory COK071781PF4 IGGGenetic Testing Institute

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.

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