Diapharma Factor X Kit

FDA 510(k) K040362 · Diapharma Group, Inc.

Substantially Equivalent

510(k) numberK040362

Submission

Device name
Diapharma Factor X Kit
Applicant
Diapharma Group, Inc.
West Chester, OH, US
Received
February 13, 2004
Decision date
July 12, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GJT – Plasma, Coagulation Factor Deficient
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7290
Specialty
Hematology

Other 510(k)s with product code GJT

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K222831CRYOcheck Factor VIII Deficient Plasma with VWFGJT · Traditional Precision Biologic, Inc.09/13/2023SE
K180486HemosIL Factor XII Deficient PlasmaGJT · Special Instrumentation Laboratory CO03/22/2018SE
K102908Nofact IxGJT · Traditional R2 Diagnostics, Inc.12/19/2011SE
K102851Nofact ViiiGJT · Traditional R2 Diagnostics, Inc.12/19/2011SE
K110237Hemosil Factor Viii Deficient PlasmaGJT · Traditional Instrumentation Laboratory CO07/08/2011SE
K050661Hemosil Factor II Deficient PlasmaGJT · Traditional Instrumentation Laboratory CO05/02/2005SE
K043459Hemosil Factor Xii Deficient PlasmaGJT · Traditional Instrumentation Laboratory CO02/09/2005SE
K034007Hemosil Factor Viii Deficient PlasmaGJT · Traditional Instrumentation Laboratory CO02/13/2004SE
K031829Hemosil Factor Ix Deficient PlasmaGJT · Traditional Instrumentation Laboratory CO07/31/2003SE
K031122Hemosil Factor X Deficient PlasmaGJT · Traditional Instrumentation Laboratory CO05/19/2003SE

Questions and answers

When was Diapharma Factor X Kit cleared by the FDA?

Diapharma Factor X Kit (K040362) received a 510(k) decision of Substantially Equivalent on July 12, 2004, 150 days after the submission was received.

What is the product code of K040362?

The FDA product code is GJT – Plasma, Coagulation Factor Deficient, a Class II (moderate risk) device regulated under 21 CFR 864.7290.