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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Automated Blood Cell Diluting
510(k) Number K791644
Device Name ROYCO MODEL 371 SUPER DILUTOR
Applicant
Royco Instruments
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Royco Instruments
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.5240
Classification Product Code
GKH  
Date Received08/23/1979
Decision Date 09/19/1979
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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