The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Blood Urea Nitrogen (bun) Procedure.
| Device ID | K861666 |
| 510k Number | K861666 |
| Device Name: | BLOOD UREA NITROGEN (BUN) PROCEDURE |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 2016 E. RANDOL MILL RD. Arlington, TX 70611 |
| Contact | Jerry A Graham |
| Correspondent | Jerry A Graham DATA MEDICAL ASSOCIATES, INC. 2016 E. RANDOL MILL RD. Arlington, TX 70611 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-30 |
| Decision Date | 1986-07-01 |