K830340 is an FDA 510(k) clearance for the FITKIT I CHECKUP KIT. This device is classified as a Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (Class I - General Controls, product code CDM).
Submitted by Boditestor (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983, 195 days after receiving the submission on February 2, 1983.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1785.
| 510(k) Number | K830340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1983 |
| Decision Date | August 16, 1983 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | CDM — Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1785 |