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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 K843093
Device Name RETIC-CHEX
Applicant
Streck Laboratories, Inc.
P.O. Box 37625
Omaha,  NE  68137
Applicant Contact HAL SORNSON
Correspondent
Streck Laboratories, Inc.
P.O. Box 37625
Omaha,  NE  68137
Correspondent Contact HAL SORNSON
Regulation Number864.8625
Classification Product Code
JPK  
Date Received08/07/1984
Decision Date 10/23/1984
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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