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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K842086
Device Name SPOTTEST LACTOPHENOL COTTON BLUE STAIN
Applicant
DIFCO LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DIFCO LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.2660
Classification Product Code
JTO  
Date Received05/24/1984
Decision Date 07/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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