The following data is part of a premarket notification filed by Remel Co. with the FDA for Urea-pda Disk.
| Device ID | K830396 |
| 510k Number | K830396 |
| Device Name: | UREA-PDA DISK |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | REMEL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-07 |
| Decision Date | 1983-03-08 |