IDA RAPID O2A SYSTEM

Kit, Anaerobic Identification

INNOVATIVE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Innovative Diagnostic Systems, Inc. with the FDA for Ida Rapid O2a System.

Pre-market Notification Details

Device IDK820483
510k NumberK820483
Device Name:IDA RAPID O2A SYSTEM
ClassificationKit, Anaerobic Identification
Applicant INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta,  GA  30340
Product CodeJSP  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-02-22
Decision Date1982-03-15

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