RAPID YEAST PLUS SYSTEM

Kit, Identification, Yeast

INNOVATIVE DIAGNOSTIC SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK943621
510k NumberK943621
Device Name:RAPID YEAST PLUS SYSTEM
ClassificationKit, Identification, Yeast
Applicant INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta,  GA  30340
ContactLouis A Eriquez, Ph.d.
CorrespondentLouis A Eriquez, Ph.d.
INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta,  GA  30340
Product CodeJXB  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-27
Decision Date1995-01-27

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