The following data is part of a premarket notification filed by Teco Diagnostics, Inc. with the FDA for Carbon Dioxide Reagent Set.
| Device ID | K170200 |
| 510k Number | K170200 |
| Device Name: | Carbon Dioxide Reagent Set |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | Teco Diagnostics, Inc. 1268 North Lakeview Avenue Anaheim, CA 92807 |
| Contact | Hyun Bin Song |
| Correspondent | Hyun Bin Song Teco Diagnostics, Inc. 1268 North Lakeview Avenue Anaheim, CA 92807 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-23 |
| Decision Date | 2017-06-01 |
| Summary: | summary |