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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 K852992
Device Name PARA CHECK (AKA EIGHT CHECK-C)
Applicant
STRECK LABORATORIES, INC.
P.O. BOX 37625
OMAHA,  NE  68137
Applicant Contact HALVOR SORNSON
Correspondent
STRECK LABORATORIES, INC.
P.O. BOX 37625
OMAHA,  NE  68137
Correspondent Contact HALVOR SORNSON
Regulation Number864.8625
Classification Product Code
JPK  
Date Received07/15/1985
Decision Date 10/10/1985
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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