K891218 is an FDA 510(k) clearance for the IQ/QCA PHOSPHORUS. This device is classified as a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I - General Controls, product code CEO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 22, 1989, 15 days after receiving the submission on March 7, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1580.
| 510(k) Number | K891218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1989 |
| Decision Date | March 22, 1989 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEO — Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1580 |