The following data is part of a premarket notification filed by California Immuno Diagnostic, Inc. with the FDA for Dia Strips System.
| Device ID | K831623 |
| 510k Number | K831623 |
| Device Name: | DIA STRIPS SYSTEM |
| Classification | Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) |
| Applicant | CALIFORNIA IMMUNO DIAGNOSTIC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CDM |
| CFR Regulation Number | 862.1785 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-20 |
| Decision Date | 1983-07-28 |