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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Microbiologic
510(k) Number K871606
Device Name SPOTTEST FLAGELLA STAIN
Applicant
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232 -7058
Applicant Contact ROBERT
Correspondent
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232 -7058
Correspondent Contact ROBERT
Regulation Number864.1850
Classification Product Code
JTS  
Date Received04/24/1987
Decision Date 05/15/1987
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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