The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Urea-sl Assay Catalogue Number 239-10, 239-30.
| Device ID | K973931 |
| 510k Number | K973931 |
| Device Name: | UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., 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 | 1997-10-15 |
| Decision Date | 1997-11-24 |