The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Biotel (tm)/uti.
| Device ID | K855238 |
| 510k Number | K855238 |
| Device Name: | BIOTEL (TM)/UTI |
| Classification | Diazo (colorimetric), Nitrite (urinary, Non-quant) |
| Applicant | AMERICAN DIAGNOSTIC CORP. P.O. BOX 89 Wheaton, IL 60189 |
| Contact | Craig Bonda |
| Correspondent | Craig Bonda AMERICAN DIAGNOSTIC CORP. P.O. BOX 89 Wheaton, IL 60189 |
| Product Code | JMT |
| CFR Regulation Number | 862.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-31 |
| Decision Date | 1986-05-09 |