The following data is part of a premarket notification filed by Wescor, Inc. with the FDA for Colloid Osmometer 4400.
| Device ID | K834208 |
| 510k Number | K834208 |
| Device Name: | COLLOID OSMOMETER 4400 |
| Classification | Osmometer For Clinical Use |
| Applicant | WESCOR, 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 | 1983-12-05 |
| Decision Date | 1984-03-23 |