RESPIRATORY SYNCYTIAL VIRUS

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

BION ENT., LTD.

The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Respiratory Syncytial Virus.

Pre-market Notification Details

Device IDK894623
510k NumberK894623
Device Name:RESPIRATORY SYNCYTIAL VIRUS
ClassificationRespiratory Syncytial Virus, Antigen, Antibody, Ifa
Applicant BION ENT., LTD. 674 BUSSE HWY. Park Ridge,  IL  60068
ContactJudy Mccormack
CorrespondentJudy Mccormack
BION ENT., LTD. 674 BUSSE HWY. Park Ridge,  IL  60068
Product CodeLKT  
CFR Regulation Number866.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-20
Decision Date1989-10-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B110RSN90100 K894623 000
B110RSG90200 K894623 000
B110RS90120 K894623 000

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