The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem Co2 Reagent.
| Device ID | K982056 |
| 510k Number | K982056 |
| Device Name: | RAICHEM CO2 REAGENT |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-09 |
| Decision Date | 1998-06-24 |
| Summary: | summary |