K790862 is an FDA 510(k) clearance for the BIOVATION DIGITAL URINOMETER. This device is classified as a Refractometer For Clinical Use (Class I - General Controls, product code JRE).
Submitted by Biovation, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1979, 52 days after receiving the submission on May 7, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2800.
| 510(k) Number | K790862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1979 |
| Decision Date | June 28, 1979 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JRE — Refractometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2800 |