The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Carbon Dioxide-l3k-c Assay, Models 288-30 And 288-80.
| Device ID | K002354 |
| 510k Number | K002354 |
| Device Name: | CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 |
| 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 | 2000-08-02 |
| Decision Date | 2000-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400348 | K002354 | 000 |
| 00628063400331 | K002354 | 000 |