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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 K883569
Device Name HISTO-CHECK GRAM NEGATIVE SLIDES
Applicant
Val Tech Diagnostics, Inc.
14 Werner Camp Rd.
Pittsburgh,  PA  15215
Applicant Contact STEVE L SINKA
Correspondent
Val Tech Diagnostics, Inc.
14 Werner Camp Rd.
Pittsburgh,  PA  15215
Correspondent Contact STEVE L SINKA
Regulation Number866.2660
Classification Product Code
LJG  
Date Received08/22/1988
Decision Date 10/06/1988
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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