The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Urea-l3k Assay, Catalogue Number 283-17/30.
| Device ID | K002694 |
| 510k Number | K002694 |
| Device Name: | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-29 |
| Decision Date | 2000-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400980 | K002694 | 000 |
| 00628063400973 | K002694 | 000 |
| 00628063400966 | K002694 | 000 |