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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K013397
Device Name PACIFIC HEMOSTASIS REFERENCE EMULSION
Original Applicant
FISHER DIAGNOSTICS
8365 valley pike
middletown,  VA  22645 -0307
Original Contact jerald p steiner
Regulation Number862.1150
Classification Product Code
JIX  
Date Received10/15/2001
Decision Date 02/15/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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