The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Carbon Dioxide Assay Kit(enzy. Single) 203-10.
| Device ID | K880866 |
| 510k Number | K880866 |
| Device Name: | CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10 |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Contact | David Templeton |
| Correspondent | David Templeton DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-04-28 |