The following data is part of a premarket notification filed by Fermco Biochemics, Inc. with the FDA for Fermcotest Co2 Reagnet.
| Device ID | K822117 |
| 510k Number | K822117 |
| Device Name: | FERMCOTEST CO2 REAGNET |
| Classification | Ph Rate Measurement, Carbon-dioxide |
| Applicant | FERMCO BIOCHEMICS, INC. 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 | 1982-07-19 |
| Decision Date | 1982-09-30 |