TRU RSV

Antisera, Cf, Poliovirus 1-3

MERIDIAN BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Tru Rsv.

Pre-market Notification Details

Device IDK071101
510k NumberK071101
Device Name:TRU RSV
ClassificationAntisera, Cf, Poliovirus 1-3
Applicant MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
ContactSusan Rolih
CorrespondentSusan Rolih
MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
Product CodeGOG  
CFR Regulation Number866.3405 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-19
Decision Date2007-10-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733101847 K071101 000
00840733101977 K071101 000

Trademark Results [TRU RSV]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRU RSV
TRU RSV
78901518 3407186 Live/Registered
Meridian Bioscience, Inc.
2006-06-06

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