The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Co2 Reagent (340 Nm).
| Device ID | K896258 |
| 510k Number | K896258 |
| Device Name: | CO2 REAGENT (340 NM) |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Mathew Madappally |
| Correspondent | Mathew Madappally SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-30 |
| Decision Date | 1990-02-13 |