K842750 is an FDA 510(k) clearance for the OSMOTIC PRESSURE AUTO & STAT OM-6010. This device is classified as a Osmometer For Clinical Use (Class I - General Controls, product code JJM).
Submitted by Kyoto Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984, 35 days after receiving the submission on July 13, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2730.
| 510(k) Number | K842750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1984 |
| Decision Date | August 17, 1984 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJM — Osmometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2730 |