The following data is part of a premarket notification filed by Cenogenics Corp. with the FDA for Uri-val.
| Device ID | K843680 |
| 510k Number | K843680 |
| Device Name: | URI-VAL |
| Classification | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality |
| Applicant | CENOGENICS CORP. 620 ROUTE 520 Morganville, NJ 07751 |
| Contact | Michael Katz |
| Correspondent | Michael Katz CENOGENICS CORP. 620 ROUTE 520 Morganville, NJ 07751 |
| Product Code | JMZ |
| CFR Regulation Number | 862.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-18 |
| Decision Date | 1985-03-29 |