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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name control, plasma, abnormal
510(k) Number K945856
Device Name POSITIVE LUPUS ANTICOAGULANT PLASMA
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
GGC  
Date Received11/14/1994
Decision Date 10/05/1995
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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