BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

BAXTER DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Bartels Herpes Simplex Virus 2 Igm Eia.

Pre-market Notification Details

Device IDK922333
510k NumberK922333
Device Name:BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
ClassificationEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
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 CodeLGC  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-13
Decision Date1992-12-15

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