The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Urea Nitrogen (gldh) Reagent Set (uv).
| Device ID | K862210 |
| 510k Number | K862210 |
| Device Name: | UREA NITROGEN (GLDH) REAGENT SET (UV) |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Contact | David L Callender |
| Correspondent | David L Callender STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-10 |
| Decision Date | 1986-07-01 |