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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 K843919
Device Name SPOTTEST LOEFFLER METHYLENE BLUE STAIN
Applicant
Difco Laboratories, Inc.
P.O. Box 1058-A
Detroit,  MI  48232
Applicant Contact ROBERT
Correspondent
Difco Laboratories, Inc.
P.O. Box 1058-A
Detroit,  MI  48232
Correspondent Contact ROBERT
Regulation Number864.1850
Classification Product Code
KFC  
Date Received10/05/1984
Decision Date 10/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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