The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Urea Nitrogen (bun).
| Device ID | K812341 |
| 510k Number | K812341 |
| Device Name: | UREA NITROGEN (BUN) |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | POINTE SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-18 |
| Decision Date | 1981-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727010575 | K812341 | 000 |