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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 K873256
Device Name MICRO-COUNT DIFFHE
Applicant
Toni Diagnostics, Inc.
1104 Eleventh St.
Wichita Falls,  TX  76301
Applicant Contact STEVEN R HACKER
Correspondent
Toni Diagnostics, Inc.
1104 Eleventh St.
Wichita Falls,  TX  76301
Correspondent Contact STEVEN R HACKER
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received08/14/1987
Decision Date 11/06/1987
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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