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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, White-Cell
510(k) Number K993126
Device Name CD-CHEX CD 34
Applicant
Streck Laboratories, Inc.
14124 Industrial Rd.
Omaha,  NE  68145
Applicant Contact HAL SORNSON
Correspondent
Streck Laboratories, Inc.
14124 Industrial Rd.
Omaha,  NE  68145
Correspondent Contact HAL SORNSON
Regulation Number864.8625
Classification Product Code
GGL  
Date Received09/20/1999
Decision Date 11/26/1999
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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