ENZYGNOST(R) ANTI-CMV IGG

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(r) Anti-cmv Igg.

Pre-market Notification Details

Device IDK913910
510k NumberK913910
Device Name:ENZYGNOST(R) ANTI-CMV IGG
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 Received1991-08-30
Decision Date1992-04-28

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