BARTELS CYTOMEGALOVIRUS IGM EIA

Antibody Igm,if, Cytomegalovirus Virus

BAXTER DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Bartels Cytomegalovirus Igm Eia.

Pre-market Notification Details

Device IDK922580
510k NumberK922580
Device Name:BARTELS CYTOMEGALOVIRUS IGM EIA
ClassificationAntibody Igm,if, Cytomegalovirus Virus
Applicant BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue,  WA  98009
ContactNancy Mallinak
CorrespondentNancy Mallinak
BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue,  WA  98009
Product CodeLKQ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-27
Decision Date1993-04-08

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