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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Leukocyte Alkaline Phosphatase
510(k) Number K904022
Device Name NITRO BLUE TETRAZOLIUM REDUCTION
Applicant
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact TAKES, PH.D
Correspondent
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact TAKES, PH.D
Regulation Number864.7660
Classification Product Code
GHD  
Date Received08/30/1990
Decision Date 12/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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