Home / 510(k) Clearances / K040362

510(k) K040362

DIAPHARMA FACTOR X KIT by Diapharma Group, Inc. — Product Code GJT

K040362 is an FDA 510(k) premarket notification submitted by Diapharma Group, Inc. for the device "DIAPHARMA FACTOR X KIT". The FDA issued a decision of Substantially Equivalent on July 12, 2004. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2004
Date Received
February 13, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Factor Deficient
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

Other clearances for product code GJT

  • K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF (September 13, 2023)
  • K180486 — HemosIL Factor XII Deficient Plasma (March 22, 2018)
  • K102851 — NOFACT VIII (December 19, 2011)
  • K102908 — NOFACT IX (December 19, 2011)
  • K110237 — HEMOSIL FACTOR VIII DEFICIENT PLASMA (July 8, 2011)
  • K050661 — HEMOSIL FACTOR II DEFICIENT PLASMA (May 2, 2005)
  • K043459 — HEMOSIL FACTOR XII DEFICIENT PLASMA (February 9, 2005)
  • K034007 — HEMOSIL FACTOR VIII DEFICIENT PLASMA (February 13, 2004)
  • K031829 — HEMOSIL FACTOR IX DEFICIENT PLASMA (July 31, 2003)
  • K031122 — HEMOSIL FACTOR X DEFICIENT PLASMA (May 19, 2003)

FDA data resources