INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

INCSTAR CORP.

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

Pre-market Notification Details

Device IDK955360
510k NumberK955360
Device Name:INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
ClassificationEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082
ContactMart Frick
CorrespondentMart Frick
INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082
Product CodeLFZ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-22
Decision Date1996-07-22
Summary:summary

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