The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Urea Kit.
| Device ID | K923506 |
| 510k Number | K923506 |
| Device Name: | UREA KIT |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-15 |
| Decision Date | 1993-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273209600 | K923506 | 000 |
| 05055273206852 | K923506 | 000 |
| 05055273206869 | K923506 | 000 |
| 05055273206890 | K923506 | 000 |
| 05055273206906 | K923506 | 000 |
| 05055273206913 | K923506 | 000 |
| 05055273206920 | K923506 | 000 |
| 05055273206937 | K923506 | 000 |
| 05055273206944 | K923506 | 000 |
| 05055273206951 | K923506 | 000 |
| 05055273206968 | K923506 | 000 |
| 05055273206975 | K923506 | 000 |
| 05055273216172 | K923506 | 000 |