MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51

Antisera, All Groups, N. Meningitidis

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Meningococcus Group B Monoclonal Antibody Zm-51.

Pre-market Notification Details

Device IDK844762
510k NumberK844762
Device Name:MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51
ClassificationAntisera, All Groups, N. Meningitidis
Applicant WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park,  NC  27709
ContactMax D Moody
CorrespondentMax D Moody
WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park,  NC  27709
Product CodeGTJ  
CFR Regulation Number866.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-07
Decision Date1985-06-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05056080501222 K844762 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.