IDS PORPHYRIN REAGENT

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 Porphyrin Reagent.

Pre-market Notification Details

Device IDK812859
510k NumberK812859
Device Name:IDS PORPHYRIN REAGENT
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta,  GA  30340
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-10-13
Decision Date1981-10-26

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