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 |