The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Urea Nitrogen Test Item Number 65408.
| Device ID | K932161 |
| 510k Number | K932161 |
| Device Name: | UREA NITROGEN TEST ITEM NUMBER 65408 |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-04 |
| Decision Date | 1993-09-08 |