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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K962966
Device Name IDS RAPID CB PLUS SYSTEM
Applicant
Innovative Diagnostic Systems, Inc.
2797 Peterson Pl.
Norcross,  GA  30071
Applicant Contact LOUIS A ERIQUEZ
Correspondent
Innovative Diagnostic Systems, Inc.
2797 Peterson Pl.
Norcross,  GA  30071
Correspondent Contact LOUIS A ERIQUEZ
Regulation Number866.2660
Classification Product Code
JTO  
Date Received07/30/1996
Decision Date 10/08/1996
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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