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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Quality Control Slides
510(k) Number K890718
Device Name GRAM STAIN CONTROL SLIDE
Applicant
Scientific Device Laboratory, Inc.
508 Zenith Dr.
Glenview,  IL  60025
Applicant Contact LIPTON PH.D.
Correspondent
Scientific Device Laboratory, Inc.
508 Zenith Dr.
Glenview,  IL  60025
Correspondent Contact LIPTON PH.D.
Regulation Number866.2660
Classification Product Code
LJG  
Date Received02/13/1989
Decision Date 03/16/1989
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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