The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Carbon Dioxide-sl Assay, Cat # 253-01.
| Device ID | K983019 |
| 510k Number | K983019 |
| Device Name: | CARBON DIOXIDE-SL ASSAY, CAT # 253-01 |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., 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 | 1998-08-31 |
| Decision Date | 1998-09-14 |