The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Ammonia-l3k Assay, Catalogue Number 233-10.
| Device ID | K033921 |
| 510k Number | K033921 |
| Device Name: | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 |
| Classification | Enzymatic Method, Ammonia |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, CA C1e 2a6 |
| Contact | Nancy Olscamp |
| Correspondent | Nancy Olscamp 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 | 2003-12-18 |
| Decision Date | 2004-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400010 | K033921 | 000 |