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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Cell Indices
510(k) Number K811741
Device Name CELL-CHEX RBC
Applicant
STRECK LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
STRECK LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.8150
Classification Product Code
KRX  
Date Received06/19/1981
Decision Date 09/24/1981
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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