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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Yeast
510(k) Number K882371
Device Name SOC SLIDE CULTURE SYSTEM
Applicant
The Cancer Center AT Wadley Institutes
9000 Harry Hines Blvd.
Dallas,  TX  75235
Applicant Contact DORN, PHD
Correspondent
The Cancer Center AT Wadley Institutes
9000 Harry Hines Blvd.
Dallas,  TX  75235
Correspondent Contact DORN, PHD
Regulation Number866.2660
Classification Product Code
JXC  
Date Received06/08/1988
Decision Date 07/18/1988
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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