COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY

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

LIGHT DIAGNOSTICS

The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Cocksackievirus B6 Monoclonal Antibody.

Pre-market Notification Details

Device IDK936254
510k NumberK936254
Device Name:COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
ClassificationAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Applicant LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula,  CA  92590
ContactRichard P Triglia
CorrespondentRichard P Triglia
LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula,  CA  92590
Product CodeGNM  
CFR Regulation Number866.3145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-30
Decision Date1995-09-08

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