BARTELS RUBELLA IGG EIA

Enzyme Linked Immunoabsorbent Assay, Rubella

BAXTER DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK922586
510k NumberK922586
Device Name:BARTELS RUBELLA IGG EIA
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue,  WA  98009
ContactMallinak
CorrespondentMallinak
BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue,  WA  98009
Product CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-27
Decision Date1992-09-17

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