BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

BION ENT., LTD.

The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Antinuclear Antibody(ana)test Kit/contr Serum.

Pre-market Notification Details

Device IDK872845
510k NumberK872845
Device Name:BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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 CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-20
Decision Date1987-08-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B110SSB10470 K872845 000
B110AN10120 K872845 000
B110AN10160 K872845 000
B110AND1800I0 K872845 000
B110AND300I0 K872845 000
B110ANK1200 K872845 000
B110ANK600 K872845 000
B110ANN10100 K872845 000
B110ANP10400 K872845 000
B110CAL10900 K872845 000
B110NUC10420 K872845 000
B110RNP10440 K872845 000
B110SCL10460 K872845 000
B110SSA10450 K872845 000
B110AN10060 K872845 000

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