RAPID NF SYSTEM

Kit, Identification, Glucose Nonfermenter

INNOVATIVE DIAGNOSTIC SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK900517
510k NumberK900517
Device Name:RAPID NF SYSTEM
ClassificationKit, Identification, Glucose Nonfermenter
Applicant INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta,  GA  30340
ContactLouis A Eriquez,phd
CorrespondentLouis A Eriquez,phd
INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta,  GA  30340
Product CodeJSW  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-02
Decision Date1990-03-13

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