BION EBV-M (VCA) TEST SYSTEM

Antibody Igm, If, Epstein-barr Virus

BION ENT., LTD.

The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Ebv-m (vca) Test System.

Pre-market Notification Details

Device IDK893240
510k NumberK893240
Device Name:BION EBV-M (VCA) TEST SYSTEM
ClassificationAntibody Igm, If, Epstein-barr Virus
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 CodeLJN  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-28
Decision Date1989-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B110EBN50100 K893240 000
B110EBM50300 K893240 000
B110EBM1200 K893240 000
B110EBG50200 K893240 000
B110EB50120 K893240 000

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