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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K920719
Device Name IVOS ANALYZER
Applicant
Hamilton Thorne Research
181 Elliott St.
100 Cummings Center-Suite 102c
Beverly,  MA  01915
Applicant Contact DOUGLAS-HAMILTON
Correspondent
Hamilton Thorne Research
181 Elliott St.
100 Cummings Center-Suite 102c
Beverly,  MA  01915
Correspondent Contact DOUGLAS-HAMILTON
Regulation Number864.5200
Classification Product Code
GKL  
Date Received02/18/1992
Decision Date 06/29/1992
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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