The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Total Co2 Reagent Set.
| Device ID | K832071 |
| 510k Number | K832071 |
| Device Name: | TOTAL CO2 REAGENT SET |
| Classification | Volumetric/manometric, Carbon-dioxide |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIE |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-27 |
| Decision Date | 1983-08-11 |