The following data is part of a premarket notification filed by Technostics Intl. with the FDA for Enzymatic Urea Nitrogen Reagent Set.
| Device ID | K860109 |
| 510k Number | K860109 |
| Device Name: | ENZYMATIC UREA NITROGEN REAGENT SET |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | TECHNOSTICS INTL. P.O. BOX 94090 Washington, MI 48094 |
| Contact | Susan Renehan |
| Correspondent | Susan Renehan TECHNOSTICS INTL. P.O. BOX 94090 Washington, MI 48094 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-13 |
| Decision Date | 1986-02-06 |