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510(k) K180486

HemosIL Factor XII Deficient Plasma by Instrumentation Laboratory CO — Product Code GJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2018
Date Received
February 23, 2018
Clearance Type
Special
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

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Other clearances for product code GJT

  • K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF (September 13, 2023)
  • K102908 — NOFACT IX (December 19, 2011)
  • K102851 — NOFACT VIII (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)
  • K040362 — DIAPHARMA FACTOR X KIT (July 12, 2004)
  • 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)