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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 K863332
Device Name ATAC 4300 HEMATOLOGY CELL COUNTER
Applicant
Turpen Laboratory Systems, Inc.
1650 Oak St.
Lakewood,  NJ  08701
Applicant Contact JON D TURPEN
Correspondent
Turpen Laboratory Systems, Inc.
1650 Oak St.
Lakewood,  NJ  08701
Correspondent Contact JON D TURPEN
Regulation Number864.5200
Classification Product Code
GKL  
Date Received08/27/1986
Decision Date 09/29/1986
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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