The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Biotel Microalbuminuria (tm).
| Device ID | K894169 |
| 510k Number | K894169 |
| Device Name: | BIOTEL MICROALBUMINURIA (TM) |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | AMERICAN DIAGNOSTIC CORP. 1301 WEST 22ND STREET, SUITE 312 Oak Brook, IL 60521 |
| Contact | Craig Bonda |
| Correspondent | Craig Bonda AMERICAN DIAGNOSTIC CORP. 1301 WEST 22ND STREET, SUITE 312 Oak Brook, IL 60521 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-15 |
| Decision Date | 1989-09-18 |