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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Surrogate
510(k) Number K902294
Device Name ACCUSCAN MICROBEAD STANDARDS
Applicant
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact TAKES, PHD
Correspondent
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact TAKES, PHD
Regulation Number862.1150
Classification Product Code
JIW  
Date Received05/22/1990
Decision Date 07/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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