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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 K960072
Device Name SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
Applicant
Biochem Immunosystems (U.S.), Inc.
1151 Hope St.
Stamford,  CT  06907
Applicant Contact RICHARD KEEN
Correspondent
Biochem Immunosystems (U.S.), Inc.
1151 Hope St.
Stamford,  CT  06907
Correspondent Contact RICHARD KEEN
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Codes
GKL   GKX  
Date Received01/05/1996
Decision Date 03/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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