ENZYGNOST ANTI-CMV/IGG + IGM

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Enzygnost Anti-cmv/igg + Igm.

Pre-market Notification Details

Device IDK901485
510k NumberK901485
Device Name:ENZYGNOST ANTI-CMV/IGG + IGM
ClassificationEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
ContactJohn E Hughes
CorrespondentJohn E Hughes
BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
Product CodeLFZ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-29
Decision Date1991-05-20

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