K860543 is an FDA 510(k) clearance for the BLOOD UREA NITROGEN (BUN) TESTCARD. This device is classified as a Electrode, Ion Specific, Urea Nitrogen (Class II - Special Controls, product code CDS).
Submitted by Ilex Corp. (Attleboro, US). The FDA issued a Cleared decision on April 21, 1986, 67 days after receiving the submission on February 13, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K860543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1986 |
| Decision Date | April 21, 1986 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDS — Electrode, Ion Specific, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |