IDS RAPID CB PLUS SYSTEM

Discs, Strips And Reagents, Microorganism Differentiation

INNOVATIVE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Innovative Diagnostic Systems, Inc. with the FDA for Ids Rapid Cb Plus System.

Pre-market Notification Details

Device IDK962966
510k NumberK962966
Device Name:IDS RAPID CB PLUS SYSTEM
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 2797 PETERSON PLACE Norcross,  GA  30071
ContactLouis A Eriquez
CorrespondentLouis A Eriquez
INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 2797 PETERSON PLACE Norcross,  GA  30071
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-30
Decision Date1996-10-08

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