The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Immunodip Urinary Albumin Screen, Model 790-01, 790-15.
| Device ID | K994035 |
| 510k Number | K994035 |
| Device Name: | IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, CA C1e 2a6 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-29 |
| Decision Date | 2000-02-01 |
| Summary: | summary |