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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Platelet
510(k) Number K823930
Device Name HEMATOLOGY QUALITY CONTROL MIXTURE
Applicant
Fisher Scientific Co., LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Fisher Scientific Co., LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.8625
Classification Product Code
GJP  
Date Received12/29/1982
Decision Date 02/01/1983
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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