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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K960557
Device Name CALIBRATION VERIFICATION ASSESSMENT (CVA)
Applicant
STRECK LABORATORIES, INC.
14306 INDUSTRIAL RD.
OMAHA,  NE  68144
Applicant Contact THEODORE W HEISE
Correspondent
STRECK LABORATORIES, INC.
14306 INDUSTRIAL RD.
OMAHA,  NE  68144
Correspondent Contact THEODORE W HEISE
Regulation Number864.8625
Classification Product Code
JPK  
Date Received02/09/1996
Decision Date 04/03/1996
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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