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510(k) K161316

George King Coumadin Plasma by George King Bio-Medical, Inc. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2017
Date Received
May 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by George King Bio-Medical, Inc.

  • K945855 — A-FACT, ABNORMAL FACTOR ASSAY CONTROL (October 24, 1995)
  • K945854 — B-FACT, BORDERLINE FACTOR ASSAY CONTROL (October 24, 1995)
  • K945857 — PROTEIN C DEFICIENT PLASMA (October 20, 1995)
  • K945856 — POSITIVE LUPUS ANTICOAGULANT PLASMA (October 5, 1995)

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  • K120014 — STA- COAG CONTROL (N+ABN) PLUS (March 14, 2013)