K822117 is an FDA 510(k) clearance for the FERMCOTEST CO2 REAGNET. This device is classified as a Ph Rate Measurement, Carbon-dioxide (Class II - Special Controls, product code JFL).
Submitted by Fermco Biochemics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982, 73 days after receiving the submission on July 19, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K822117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1982 |
| Decision Date | September 30, 1982 |
| Days to Decision | 73 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 |