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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Cell Counter, Normal And Abnormal
510(k) Number K896154
Device Name PARA TECH FOR TECHNICON H-1
Applicant
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Applicant Contact HALVOR SORNSON
Correspondent
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Correspondent Contact HALVOR SORNSON
Regulation Number864.8625
Classification Product Code
JCN  
Date Received10/24/1989
Decision Date 11/09/1989
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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