The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Baker Diag. Ultrarate Co2 Reagent Kit.
| Device ID | K802035 |
| 510k Number | K802035 |
| Device Name: | BAKER DIAG. ULTRARATE CO2 REAGENT KIT |
| Classification | Ph Rate Measurement, Carbon-dioxide |
| Applicant | J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JFL |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-22 |
| Decision Date | 1980-09-26 |