The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Ammonia-l3k Assay, Model 263-17, Ammonia-l3k Assay, Model 263-30.
| Device ID | K001285 |
| 510k Number | K001285 |
| Device Name: | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 |
| Classification | Enzymatic Method, Ammonia |
| 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 | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-21 |
| Decision Date | 2000-06-02 |