The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25.
| Device ID | K022538 |
| 510k Number | K022538 |
| Device Name: | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 26371 EVA ST. Laguna Hills, CA 92656 |
| Contact | Mike Berg |
| Correspondent | Mike Berg DIAGNOSTIC CHEMICALS, LTD. (USA) 26371 EVA ST. Laguna Hills, CA 92656 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-01 |
| Decision Date | 2002-08-23 |