The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Carbon Dioxide - L3k Assay, Catalogue Number 299-30/40/50.
| Device ID | K990754 |
| 510k Number | K990754 |
| Device Name: | CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 |
| Classification | Enzymatic, Carbon-dioxide |
| 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 | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-08 |
| Decision Date | 1999-04-20 |