K904116 is an FDA 510(k) clearance for the IRON 5 X CONC REAGENT. This device is classified as a Ferrozine (colorimetric) Iron Binding Capacity (Class I - General Controls, product code JMO).
Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on September 27, 1990, 21 days after receiving the submission on September 6, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1415.
| 510(k) Number | K904116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1990 |
| Decision Date | September 27, 1990 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JMO — Ferrozine (colorimetric) Iron Binding Capacity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1415 |