| K-number | K855238 |
| Device name | BIOTEL (TM)/UTI |
| Applicant | American Diagnostic Corp. |
| Product code | JMT |
| Device class | Class I |
| Decision date | May 9, 1986 |
| Decision | Substantially Equivalent |
| Regulation | 862.1510 |
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