The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Urea-l3k Assay, Catalogue Number 283-17/10/30/50.
| Device ID | K993178 |
| 510k Number | K993178 |
| Device Name: | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| 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 | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-23 |
| Decision Date | 1999-10-18 |