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510(k) K945857

PROTEIN C DEFICIENT PLASMA by George King Bio-Medical, Inc. — Product Code GJT

K945857 is an FDA 510(k) premarket notification submitted by George King Bio-Medical, Inc. for the device "PROTEIN C DEFICIENT PLASMA". The FDA issued a decision of Substantially Equivalent on October 20, 1995. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290. George King Bio-Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1995
Date Received
November 14, 1994
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 by George King Bio-Medical, Inc.

  • K161316 — George King Coumadin Plasma (February 23, 2017)
  • K945855 — A-FACT, ABNORMAL FACTOR ASSAY CONTROL (October 24, 1995)
  • K945854 — B-FACT, BORDERLINE FACTOR ASSAY CONTROL (October 24, 1995)
  • K945856 — POSITIVE LUPUS ANTICOAGULANT PLASMA (October 5, 1995)

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)
  • 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)

FDA data resources