INCSTAR RUBELLA IGG FAST ELISA ASSAY

Enzyme Linked Immunoabsorbent Assay, Rubella

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar Rubella Igg Fast Elisa Assay.

Pre-market Notification Details

Device IDK960358
510k NumberK960358
Device Name:INCSTAR RUBELLA IGG FAST ELISA ASSAY
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082
ContactMary Frick
CorrespondentMary Frick
INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082
Product CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-25
Decision Date1996-10-24
Summary:summary

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