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FDA 510(k)

HEMOSIL FACTOR VIII DEFICIENT PLASMA

K-Number: K034007 · 2004-02-13

ApplicantInstrumentation Laboratory CO
Decision Date2004-02-13
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSIL FACTOR VIII DEFICIENT PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2004-02-13 under 510(k) number K034007. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSIL FACTOR VIII DEFICIENT PLASMA?

HEMOSIL FACTOR VIII DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 2004-02-13. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K034007.

When did HEMOSIL FACTOR VIII DEFICIENT PLASMA receive FDA 510(k) clearance?

HEMOSIL FACTOR VIII DEFICIENT PLASMA received FDA 510(k) clearance on 2004-02-13, under 510(k) number K034007.

Who is the listed applicant for HEMOSIL FACTOR VIII DEFICIENT PLASMA?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOSIL FACTOR VIII DEFICIENT PLASMA?

The FDA product code for HEMOSIL FACTOR VIII DEFICIENT PLASMA is GJT.

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Other records listing Instrumentation Laboratory CO 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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Related Devices (Code: GJT)

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.

K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory COK102851NOFACT VIIIR2 Diagnostics, Inc.K102908NOFACT IXR2 Diagnostics, Inc.K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory COK050661HEMOSIL FACTOR II DEFICIENT PLASMAInstrumentation Laboratory 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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