The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Modification To Carbon Dioxide-l3k Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 And 299-12.
| Device ID | K042362 |
| 510k Number | K042362 |
| Device Name: | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 |
| Classification | Enzymatic, Carbon-dioxide |
| 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 | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-31 |
| Decision Date | 2004-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400324 | K042362 | 000 |
| 00628063400317 | K042362 | 000 |
| 00628063400300 | K042362 | 000 |
| 00628063400294 | K042362 | 000 |
| 00628063400287 | K042362 | 000 |
| 00628063400003 | K042362 | 000 |