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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K882485
Device Name DIVERSI-KIT
Applicant
Intl. Cancer Screening Laboratories, Inc.
3370 Nacogdoches Rd., Suite 100
San Antonio,  TX  78217
Applicant Contact BOUGHTON, III
Correspondent
Intl. Cancer Screening Laboratories, Inc.
3370 Nacogdoches Rd., Suite 100
San Antonio,  TX  78217
Correspondent Contact BOUGHTON, III
Regulation Number866.2900
Classification Product Code
LIO  
Date Received06/16/1988
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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