The following data is part of a premarket notification filed by Boditestor with the FDA for Fitkit I Checkup Kit.
| Device ID | K830340 |
| 510k Number | K830340 |
| Device Name: | FITKIT I CHECKUP KIT |
| Classification | Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) |
| Applicant | BODITESTOR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDM |
| CFR Regulation Number | 862.1785 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-02 |
| Decision Date | 1983-08-16 |