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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 K853036
Device Name PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
Applicant
Diagnostic Technology, Inc.
240 Vanderbilt Motor Pkwy.
Hauppauge,  NY  11788
Applicant Contact ROBERT E LIND
Correspondent
Diagnostic Technology, Inc.
240 Vanderbilt Motor Pkwy.
Hauppauge,  NY  11788
Correspondent Contact ROBERT E LIND
Regulation Number864.5200
Classification Product Code
GKL  
Date Received07/18/1985
Decision Date 11/05/1985
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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