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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Fibrinogen Control
510(k) Number K946193
Device Name FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3
Applicant
MORE DIAGNOSTICS
P.O. BOX 6714
LOS OSOS,  CA  93412
Applicant Contact JAMES W SNIPES
Correspondent
MORE DIAGNOSTICS
P.O. BOX 6714
LOS OSOS,  CA  93412
Correspondent Contact JAMES W SNIPES
Regulation Number864.7340
Classification Product Code
GIL  
Date Received12/20/1994
Decision Date 08/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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