The following data is part of a premarket notification filed by Kyoto Diagnostics, Inc. with the FDA for Osmotic Pressure Auto & Stat Om-6010.
| Device ID | K842750 |
| 510k Number | K842750 |
| Device Name: | OSMOTIC PRESSURE AUTO & STAT OM-6010 |
| Classification | Osmometer For Clinical Use |
| Applicant | KYOTO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJM |
| CFR Regulation Number | 862.2730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-13 |
| Decision Date | 1984-08-17 |