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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 K840515
Device Name ACID FAST BACILLI STAIN CONTROL
Applicant
Scientific Device Laboratory, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Scientific Device Laboratory, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2660
Classification Product Code
LJG  
Date Received02/06/1984
Decision Date 03/09/1984
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
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