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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 K860166
Device Name PICOSCALE BLOOD CELL COUNTER, MODEL PS-5
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 Received01/17/1986
Decision Date 04/04/1986
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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