The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urea Nitrogen (bun) Liquid Reagent.
| Device ID | K981106 |
| 510k Number | K981106 |
| Device Name: | UREA NITROGEN (BUN) LIQUID REAGENT |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Contact | Rhoda Filipina |
| Correspondent | Rhoda Filipina TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-26 |
| Decision Date | 1998-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001235 | K981106 | 000 |
| 10673486001228 | K981106 | 000 |