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 |