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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Candida Spp., Direct Antigen, Id
510(k) Number K883118
Device Name ON THE SPOT CANDIDASURE
Applicant
Medi-Tech, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Applicant Contact JULIE DEMARCO
Correspondent
Medi-Tech, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Correspondent Contact JULIE DEMARCO
Regulation Number866.3165
Classification Product Code
LRF  
Date Received07/25/1988
Decision Date 09/30/1988
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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