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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Red-Cell
510(k) Number K000076
Device Name CELL-CHEX
Applicant
STRECK LABORATORIES, INC.
14124 INDUSTRIAL RD.
OMAHA,  NE  68145 -0625
Applicant Contact PAUL KITTELSON
Correspondent
STRECK LABORATORIES, INC.
14124 INDUSTRIAL RD.
OMAHA,  NE  68145 -0625
Correspondent Contact PAUL KITTELSON
Regulation Number864.8625
Classification Product Code
GJR  
Date Received01/10/2000
Decision Date 03/03/2000
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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