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.
Device ID | K872845 |
510k Number | K872845 |
Device Name: | BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM |
Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
Applicant | BION ENT., LTD. 674 BUSSE HWY. Park Ridge, IL 60068 |
Contact | Edward Nowakowski |
Correspondent | Edward Nowakowski BION ENT., LTD. 674 BUSSE HWY. Park Ridge, IL 60068 |
Product Code | DHN |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-20 |
Decision Date | 1987-08-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |