K061464 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541. This device is classified as a Ferrozine (colorimetric) Iron Binding Capacity (Class I - General Controls, product code JMO).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 15, 2006, 21 days after receiving the submission on May 25, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1415.
| 510(k) Number | K061464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2006 |
| Decision Date | June 15, 2006 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JMO — Ferrozine (colorimetric) Iron Binding Capacity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1415 |