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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methylene Blue, Tissue Stain
510(k) Number K770792
Device Name TUBE, STAIN, RETICULOCYTE, LARC
Applicant
Corning Medical & Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Corning Medical & Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.1850
Classification Product Code
KFC  
Date Received05/02/1977
Decision Date 07/05/1977
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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