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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plasma, coagulation control
510(k) Number K945854
Device Name B-FACT, BORDERLINE FACTOR ASSAY CONTROL
Applicant
George King Bio-Medical, Inc.
11771 WEST 112TH ST.
OVERLAND PARK,  KS  66210
Applicant Contact JUDITH A GILLISSEN
Correspondent
George King Bio-Medical, Inc.
11771 WEST 112TH ST.
OVERLAND PARK,  KS  66210
Correspondent Contact JUDITH A GILLISSEN
Regulation Number864.5425
Classification Product Code
GGN  
Date Received11/14/1994
Decision Date 10/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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