Bion Ent., Ltd. · Class II · Cleared Aug 17, 1987
| K-number | K872845 |
| Device name | BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM |
| Applicant | Bion Ent., Ltd. |
| Product code | DHN |
| Device class | Class II |
| Decision date | Aug 17, 1987 |
| Decision | Substantially Equivalent |
| Regulation | 866.5100 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov