BION CMV-G TEST SYSTEM

Antigen, Cf (including Cf Control), Cytomegalovirus

BION ENT., LTD.

The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Cmv-g Test System.

Pre-market Notification Details

Device IDK880679
510k NumberK880679
Device Name:BION CMV-G TEST SYSTEM
ClassificationAntigen, Cf (including Cf Control), Cytomegalovirus
Applicant BION ENT., LTD. 674 BUSSE HWY. Park Ridge,  IL  60068
ContactEdward Nowakowski
CorrespondentEdward Nowakowski
BION ENT., LTD. 674 BUSSE HWY. Park Ridge,  IL  60068
Product CodeGQH  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-19
Decision Date1988-06-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B110CMN20100 K880679 000
B110CMM20300 K880679 000
B110CMG20200 K880679 000
B110CMG1200 K880679 000
B110CM20120 K880679 000

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