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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
Applicant
Fisher Diagnostics
8365 Valley Pike
Middletown,  VA  22645
Applicant Contact JERALD P STEINER
Correspondent
Fisher Diagnostics
8365 Valley Pike
Middletown,  VA  22645
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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