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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 K781146
Device Name HEMAC LASER HEMATOLOGY SYSTEM
Applicant
Ortho Instruments
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ortho Instruments
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.5200
Classification Product Code
GKL  
Date Received07/10/1978
Decision Date 09/14/1978
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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