RUBENOSTIKA IGG MICROELISA SYSTEM

Enzyme Linked Immunoabsorbent Assay, Rubella

ORGANON TEKNIKA CORP.

The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Rubenostika Igg Microelisa System.

Pre-market Notification Details

Device IDK911393
510k NumberK911393
Device Name:RUBENOSTIKA IGG MICROELISA SYSTEM
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham,  NC  27712
ContactAnn M Quinn
CorrespondentAnn M Quinn
ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham,  NC  27712
Product CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-29
Decision Date1991-04-29

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