The following data is part of a premarket notification filed by Ilex Corp. with the FDA for Blood Urea Nitrogen (bun) Testcard.
| Device ID | K860543 |
| 510k Number | K860543 |
| Device Name: | BLOOD UREA NITROGEN (BUN) TESTCARD |
| Classification | Electrode, Ion Specific, Urea Nitrogen |
| Applicant | ILEX CORP. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | William A Morton |
| Correspondent | William A Morton ILEX CORP. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | CDS |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-13 |
| Decision Date | 1986-04-21 |