Architect CMV IgG

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Abbott Laboratories

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Cmv Igg.

Pre-market Notification Details

Device IDK220949
510k NumberK220949
Device Name:Architect CMV IgG
ClassificationEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant Abbott Laboratories Dept 09AA, Bldg. AP8A, 100 Abbott Park Rd. Abbott Park,  IL  60064
ContactShannon Reibling
CorrespondentShannon Reibling
Abbott Laboratories Dept 09AA, Bldg. AP8A, 100 Abbott Park Rd. Abbott Park,  IL  60064
Product CodeLFZ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-01
Decision Date2022-10-27

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