K802035 is an FDA 510(k) clearance for the BAKER DIAG. ULTRARATE CO2 REAGENT KIT. This device is classified as a Ph Rate Measurement, Carbon-dioxide (Class II - Special Controls, product code JFL).
Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980, 35 days after receiving the submission on August 22, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K802035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1980 |
| Decision Date | September 26, 1980 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JFL — Ph Rate Measurement, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |