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FDA 510(k)

GTI-FVIII INHIBITOR ASSAY

K-Number: K993553 · 2000-02-01

ApplicantGenetic Testing Institute
Decision Date2000-02-01
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GTI-FVIII INHIBITOR ASSAY 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 2000-02-01 under 510(k) number K993553. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GTI-FVIII INHIBITOR ASSAY?

GTI-FVIII INHIBITOR ASSAY is a medical device that received FDA 510(k) clearance on 2000-02-01. The listed applicant is Genetic Testing Institute. The 510(k) number is K993553.

When did GTI-FVIII INHIBITOR ASSAY receive FDA 510(k) clearance?

GTI-FVIII INHIBITOR ASSAY received FDA 510(k) clearance on 2000-02-01, under 510(k) number K993553.

Who is the listed applicant for GTI-FVIII INHIBITOR ASSAY?

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 GTI-FVIII INHIBITOR ASSAY?

The FDA product code for GTI-FVIII INHIBITOR ASSAY is GGP.

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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 IGGK053559PF4 ENHANCED SOLID PHASE ELISAK983379GTI-PF4 ELISAK841114ALLO-TYPE HUMAN IMMUNOGLOBULIN-

Related Devices (Code: GGP)

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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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