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FDA 510(k)

FACTOR VIII ANTIBODY SCREEN

K-Number: K082205 · 2008-11-20

ApplicantGenetic Testing Institute
Decision Date2008-11-20
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACTOR VIII ANTIBODY SCREEN 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 2008-11-20 under 510(k) number K082205. 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 FACTOR VIII ANTIBODY SCREEN?

FACTOR VIII ANTIBODY SCREEN is a medical device that received FDA 510(k) clearance on 2008-11-20. The listed applicant is Genetic Testing Institute. The 510(k) number is K082205.

When did FACTOR VIII ANTIBODY SCREEN receive FDA 510(k) clearance?

FACTOR VIII ANTIBODY SCREEN received FDA 510(k) clearance on 2008-11-20, under 510(k) number K082205.

Who is the listed applicant for FACTOR VIII ANTIBODY SCREEN?

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 FACTOR VIII ANTIBODY SCREEN?

The FDA product code for FACTOR VIII ANTIBODY SCREEN 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.

K071781PF4 IGGK053559PF4 ENHANCED SOLID PHASE ELISAK993553GTI-FVIII INHIBITOR ASSAYK983379GTI-PF4 ELISAK841114ALLO-TYPE HUMAN IMMUNOGLOBULIN-

Related Devices (Code: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation 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.

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