COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY

Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

CHEMICON INTL., INC.

The following data is part of a premarket notification filed by Chemicon Intl., Inc. with the FDA for Coxsackievirus B1 Monoclonal Antibody.

Pre-market Notification Details

Device IDK936145
510k NumberK936145
Device Name:COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY
ClassificationAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Applicant CHEMICON INTL., INC. 28835 SINGLE OAK DR. Temecula,  CA  92590
ContactPricilla Zia
CorrespondentPricilla Zia
CHEMICON INTL., INC. 28835 SINGLE OAK DR. Temecula,  CA  92590
Product CodeGNM  
CFR Regulation Number866.3145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-27
Decision Date1995-09-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04053252326264 K936145 000

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