QUICKLAB RSV

Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

INTEGRATED BIOTECHNOLOGY CORP.

The following data is part of a premarket notification filed by Integrated Biotechnology Corp. with the FDA for Quicklab Rsv.

Pre-market Notification Details

Device IDK021789
510k NumberK021789
Device Name:QUICKLAB RSV
ClassificationAntigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Applicant INTEGRATED BIOTECHNOLOGY CORP. 366 RIDGEPOINT DR. Carmel,  IN  46032
ContactSally A Booth
CorrespondentSally A Booth
INTEGRATED BIOTECHNOLOGY CORP. 366 RIDGEPOINT DR. Carmel,  IN  46032
Product CodeGQG  
CFR Regulation Number866.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-31
Decision Date2002-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00722066008034 K021789 000

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