BARTELS RUBEOLA IGM EIA

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

BAXTER DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK922335
510k NumberK922335
Device Name:BARTELS RUBEOLA IGM EIA
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
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 CodeLJB  
CFR Regulation Number866.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-13
Decision Date1992-09-02

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