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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation, Automated
510(k) Number K023362
Device Name FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN
Applicant
FISHER DIAGNOSTICS
8365 VALLEY PIKE
MIDDLETOWN,  VA  22645 -0307
Applicant Contact JERALD STEINER
Correspondent
FISHER DIAGNOSTICS
8365 VALLEY PIKE
MIDDLETOWN,  VA  22645 -0307
Correspondent Contact JERALD STEINER
Regulation Number864.5400
Classification Product Code
GKP  
Subsequent Product Code
GIS  
Date Received10/07/2002
Decision Date 12/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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