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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Red-Cell And White-Cell Counting
510(k) Number K943268
Device Name SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
Applicant
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Applicant Contact THEODORE W HEISE
Correspondent
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Correspondent Contact THEODORE W HEISE
Regulation Number864.8185
Classification Product Code
KSA  
Date Received07/07/1994
Decision Date 12/15/1994
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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