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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hand-Tally, Differential
510(k) Number K854685
Device Name DIGITAL-9 KEY LEUCOCYTE COUNTER
Applicant
Future Impex Corp.
2076 Deer Park Ave.
Deerpark,  NY  11729
Applicant Contact MORAD DAVOUDZADEH
Correspondent
Future Impex Corp.
2076 Deer Park Ave.
Deerpark,  NY  11729
Correspondent Contact MORAD DAVOUDZADEH
Regulation Number864.6160
Classification Product Code
GKM  
Date Received11/20/1985
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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