The following data is part of a premarket notification filed by Chem-elec, Inc. with the FDA for Chloride/carbon Dioxide Rate Reagent.
| Device ID | K811701 |
| 510k Number | K811701 |
| Device Name: | CHLORIDE/CARBON DIOXIDE RATE REAGENT |
| Classification | Coulometric, Chloride |
| Applicant | CHEM-ELEC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JFS |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-16 |
| Decision Date | 1981-07-01 |