Biotrol, USA, Inc. · Class II · Cleared Nov 29, 1988
| K-number | K884480 |
| Device name | BIOTROL BILIRUBIN MONOREACTIF |
| Applicant | Biotrol, USA, Inc. |
| Product code | CIC |
| Device class | Class II |
| Decision date | Nov 29, 1988 |
| Decision | Substantially Equivalent |
| Regulation | 862.1145 |
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