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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 K931825
Device Name CD-CHEX CD4 LOW
Applicant
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Applicant Contact HAL SORNSON
Correspondent
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Correspondent Contact HAL SORNSON
Regulation Number864.8625
Classification Product Code
GGL  
Date Received04/06/1993
Decision Date 06/06/1994
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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