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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Sickle Cell
510(k) Number K023656
Device Name SICKLE-CHEX SOLUBILITY KIT
Applicant
Streck Laboratories, Inc.
7002 S. 109th St.
La Vista,  NE  68128
Applicant Contact CAROL THOMPSON
Correspondent
Streck Laboratories, Inc.
7002 S. 109th St.
La Vista,  NE  68128
Correspondent Contact CAROL THOMPSON
Regulation Number864.7825
Classification Product Code
GHM  
Date Received10/30/2002
Decision Date 12/30/2002
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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