COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM

System, Transport, Aerobic

COPAN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Copan Diagnostics, Inc. with the FDA for Copan Easy-swab Collection And Transport System.

Pre-market Notification Details

Device IDK993161
510k NumberK993161
Device Name:COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
ClassificationSystem, Transport, Aerobic
Applicant COPAN DIAGNOSTICS, INC. 49 PLAIN ST. North Attleboro,  MA  02760
ContactMary Mcnamara-cullinane
CorrespondentMary Mcnamara-cullinane
COPAN DIAGNOSTICS, INC. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeJTW  
CFR Regulation Number866.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-22
Decision Date1999-11-09
Summary:summary

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