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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, identification, yeast
510(k) Number K943621
Device Name RAPID YEAST PLUS SYSTEM
Applicant
INNOVATIVE DIAGNOSTIC SYSTEMS, INC.
3404 OAKCLIFF RD. #C-1
ATLANTA,  GA  30340
Applicant Contact LOUIS A ERIQUEZ, PH.D.
Correspondent
INNOVATIVE DIAGNOSTIC SYSTEMS, INC.
3404 OAKCLIFF RD. #C-1
ATLANTA,  GA  30340
Correspondent Contact LOUIS A ERIQUEZ, PH.D.
Regulation Number866.2660
Classification Product Code
JXB  
Date Received07/27/1994
Decision Date 01/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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