K863901 is an FDA 510(k) clearance for the IQ UREA NITROGEN. This device is classified as a O-phthalaldehyde, Urea Nitrogen (Class II - Special Controls, product code JGZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on November 24, 1986, 48 days after receiving the submission on October 7, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K863901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1986 |
| Decision Date | November 24, 1986 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGZ — O-phthalaldehyde, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |