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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K770550
Device Name ATYPIA PROFILE MONITOR
Applicant
Geometric Data, Div. Smithkline Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Geometric Data, Div. Smithkline Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/21/1977
Decision Date 06/17/1977
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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