COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES

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 B Blend Monoclonal Antibodies.

Pre-market Notification Details

Device IDK940471
510k NumberK940471
Device Name:COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES
ClassificationAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Applicant CHEMICON INTL., INC. 28835 SINGLE OAK DR. Temecula,  CA  92590
ContactRichard P Triglia
CorrespondentRichard P Triglia
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 Received1994-02-02
Decision Date1995-09-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04053252734557 K940471 000
04053252729225 K940471 000
04053252404290 K940471 000
04061841171218 K940471 000

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